Medtronic

All SynchroMed EL and SynchroMed II pumps.

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.

Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. || The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.

All SynchroMed EL and SynchroMed II pumps.

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.

Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. || The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.

All SynchroMed EL and SynchroMed II pumps.

General Hospital and Personal Use Devices

3

Yes

Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.

Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. || The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency.

Lot Serial No PZM600131S PZM600054S PZM600616S PZM600617S PZM600620S PZM600615S PZM600523S PZM600111S PZM600213S PZM600502S PZM600595S PZM600600S PZM600277S PZM600078S PZM600581S PZM600582S PZM600597S PZM600602S PZM600530S PZM600108S PZM600495S PZM600497S PZM600498S PZM600500S PZM600501S PZM600151S PZM600152S PZM600153S PZM600446S PZM600447S PZM600448S PZM600264S PZM600278S PZM600469S PZM600094S PZM600401S PZM600052S PZM600053S PZM600517S PZM600621S PZM600622S PZM600233S PZM600539S PZM600129S PZM600130S PZM600132S PZM600160S PZM600162S PZM600207S PZM600208S PZM600138S PZM600140S PZM600145S PZM600146S PZM600148S PZM600156S PZM600198S PZM600056S PZM600092S PZM600104S PZM600105S PZM600147S PZM600168S PZM600252S PZM600051S PZM600199S PZM600057S PZM600273S PZM600075S PZM600232S PZM600472S PZM600049S PZM600203S PZM600276S PZM600071S PZM600143S PZM600098S PZM600110S PZM600167S PZM600101S PZM600109S PZM600126S PZM600150S PZM600491S PZM600492S PZM600080S PZM600081S PZM600281S PZM600282S PZM600283S PZM600284S PZM600285S PZM600286S PZM600287S PZM600288S PZM600289S PZM600290S PZM600184S PZM600192S PZM600245S PZM600180S PZM600262S PZM600526S PZM600643S PZM600473S PZM600186S PZM600189S PZM600243S PZM600266S PZM600247S PZM600254S PZM600556S PZM600557S PZM600558S PZM600559S PZM600560S PZM600561S PZM600562S PZM600563S PZM600584S PZM600586S PZM600112S PZM600544S PZM600599S PZM600486S PZM600405S PZM600406S PZM600407S PZM600408S PZM600409S PZM600410S PZM600411S PZM600412S PZM600413S PZM600414S PZM600415S PZM600416S PZM600417S PZM600418S PZM600419S PZM600420S PZM600421S PZM600422S PZM600423S PZM600424S PZM600425S PZM600426S PZM600427S PZM600428S PZM600429S PZM600430S PZM600431S PZM600432S PZM600433S PZM600434S PZM600435S PZM600436S PZM600437S PZM600438S PZM600439S PZM600440S PZM600441S PZM600442S PZM600443S PZM600444S PZM600445S PZM600059S PZM600060S PZM600061S PZM600062S PZM600063S PZM600064S PZM600065S PZM600066S PZM600135S PZM600136S PZM600137S PZM600116S PZM600117S PZM600118S PZM600119S PZM600120S PZM600121S PZM600122S PZM600123S PZM600124S PZM600125S PZM600079S PZM600206S PZM600578S PZM600215S PZM600216S PZM600217S PZM600218S PZM600219S PZM600220S PZM600221S PZM600222S PZM600223S PZM600224S PZM600265S PZM600083S PZM600470S PZM600528S PZM600533S PZM600640S PZM600577S PZM600076S PZM600594S PZM600241S PZM600242S PZM600272S PZM600274S PZM600573S PZM600574S PZM600576S PZM600161S PZM600163S PZM600234S PZM600133S PZM600134S PZM600193S PZM600194S PZM600090S PZM600509S PZM600072S PZM600142S PZM600173S PZM600623S PZM600624S PZM600482S PZM600196S PZM600197S PZM600535S PZM600536S PZM600067S PZM600068S PZM600077S PZM600490S PZM600190S PZM600611S PZM600612S PZM600084S PZM600087S PZM600088S PZM600089S PZM600231S PZM600201S PZM600202S PZM600141S PZM600471S PZM600546S PZM600235S PZM600236S PZM600048S PZM600128S PZM600550S PZM600551S PZM600073S PZM600085S PZM600055S PZM600158S PZM600251S PZM600165S PZM600280S PZM600070S PZM600170S PZM600204S PZM600097S PZM600545S PZM600058S PZM600166S PZM600587S PZM600512S PZM600513S PZM600291S PZM600292S PZM600293S PZM600107S PZM600510S PZM600050S PZM600149S PZM600102S PZM600238S PZM600240S PZM600598S PZM600601S PZM600086S PZM600091S PZM600596S PZM600099S PZM600100S PZM600093S PZM600155S PZM600157S PZM600159S PZM600253S PZM600171S PZM600590S PZM600493S PZM600074S PZM600209S PZM600580S PZM600494S PZM600069S PZM600200S PZM600144S PZM600154S PZM600047S PZM600095S PZM600275S PZM600547S PZM600225S PZM600113S PZM600613S PZM600614S PZM600542S PZM600237S PZM600402S PZM600403S PZM600404S PZM600514S PZM600515S PZM600258S PZM600259S PZM600487S PZM600248S PZM600279S PZM600508S PZM600256S PZM600257S PZM600608S PZM600609S PZM600488S PZM600489S PZM600261S PZM600263S PZM600641S PZM600642S PZM600270S PZM600516S PZM600589S PZM600592S PZM600255S PZM600249S PZM600169S PZM600172S PZM600174S PZM600175S PZM600176S PZM600177S PZM600178S PZM600179S PZM600181S PZM600182S PZM600183S PZM600187S PZM600191S PZM600246S PZM600474S PZM600644S PZM600507S PZM600543S PZM600250S PZM600244S PZM600534S PZM600548S PZM600549S PZM600537S PZM600538S PZM600552S PZM600553S PZM600185S PZM600188S PZM600521S PZM600522S PZM600271S PZM600527S PZM600607S PZM600627S PZM600555S PZM600646S PZM600294S PZM600295S PZM600511S PZM600713S PZM600714S PZM600260S PZM600524S PZM600525S PZM600554S PZM600268S PZM600269S PZM600475S PZM600476S PZM600477S PZM600214S PZM600541S PZM600210S PZM600212S PZM600520S PZM600540S PZM600114S PZM600115S PZM600226S PZM600229S PZM600230S PZM600483S PZM600484S PZM600485S PZM600529S PZM600205S PZM600572S PZM600575S PZM600267S PZM600106S PZM600164S PZM600103S and PZM600645S.

Cardiovascular Devices

3

Yes

No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.

Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.

Lot Serial No PZN600430S PZN600431S PZN600436S PZN600428S PZN600422S PZN600385S PZN600317S PZN600383S PZN600308S PZN600418S PZN600388S PZN600409S PZN600410S PZN600250S PZN600391S PZN600392S PZN600374S PZN600375S PZN600116S PZN600333S PZN600334S PZN600335S PZN600336S PZN600337S PZN600145S PZN600146S PZN600147S PZN600148S PZN600348S PZN600349S PZN600057S PZN600058S PZN600351S PZN600352S PZN600247S PZN600248S PZN600328S PZN600462S PZN600419S PZN600199S PZN600200S PZN600129S PZN600130S PZN600131S PZN600132S PZN600134S PZN600151S PZN600152S PZN600153S PZN600154S PZN600167S PZN600181S PZN600182S PZN600201S PZN600208S PZN600209S PZN600210S PZN600211S PZN600212S PZN600213S PZN600214S PZN600249S PZN600325S PZN600326S PZN600327S PZN600329S PZN600330S PZN600362S PZN600381S PZN600463S PZN600464S PZN600082S PZN600083S PZN600084S PZN600085S PZN600086S PZN600071S PZN600088S PZN600149S PZN600138S PZN600079S PZN600429S PZN600442S PZN600101S PZN600135S PZN600140S PZN600183S PZN600111S PZN600067S PZN600361S PZN600074S PZN600055S PZN600107S PZN600143S PZN600170S PZN600171S PZN600266S PZN600169S PZN600341S PZN600254S PZN600255S PZN600256S PZN600257S PZN600258S PZN600259S PZN600260S PZN600261S PZN600262S PZN600263S PZN600197S PZN600237S PZN600239S PZN600219S PZN600246S PZN600236S PZN600203S PZN600227S PZN600252S PZN600164S PZN600202S PZN600396S PZN600397S PZN600398S PZN600399S PZN600400S PZN600401S PZN600402S PZN600403S PZN600404S PZN600405S PZN600425S PZN600426S PZN600427S PZN600196S PZN600318S PZN600195S PZN600354S PZN600316S PZN600127S PZN600123S PZN600313S PZN600312S PZN600268S PZN600269S PZN600270S PZN600271S PZN600272S PZN600273S PZN600274S PZN600275S PZN600276S PZN600277S PZN600278S PZN600060S PZN600061S PZN600062S PZN600063S PZN600064S PZN600574S PZN600136S PZN600137S PZN600359S PZN600547S PZN600251S PZN600370S PZN600372S PZN600114S PZN600117S PZN600184S PZN600185S PZN600186S PZN600187S PZN600188S PZN600189S PZN600190S PZN600191S PZN600307S PZN600103S PZN600379S PZN600380S PZN600087S PZN600407S PZN600408S PZN600180S PZN600363S PZN600364S PZN600365S PZN600366S PZN600414S PZN600415S PZN600465S PZN600466S PZN600467S PZN600133S PZN600166S PZN600100S PZN600075S PZN600340S PZN600115S PZN600434S PZN600435S PZN600320S PZN600168S PZN600068S PZN600069S PZN600324S PZN600078S PZN600423S PZN600094S PZN600420S PZN600097S PZN600098S PZN600099S PZN600122S PZN600090S PZN600091S PZN600175S PZN600176S PZN600141S PZN600303S PZN600304S PZN600389S PZN600206S PZN600207S PZN600049S PZN600050S PZN600053S PZN600054S PZN600128S PZN600424S PZN600073S PZN600095S PZN600076S PZN600077S PZN600059S PZN600080S PZN600139S PZN600155S PZN600302S PZN600350S PZN600105S PZN600106S PZN600215S PZN600216S PZN600546S PZN600144S PZN600118S PZN600119S PZN600120S PZN600052S PZN600437S PZN600438S PZN600439S PZN600112S PZN600113S PZN600440S PZN600441S PZN600096S PZN600241S PZN600109S PZN600110S PZN600102S PZN600065S PZN600072S PZN600331S PZN600066S PZN600081S PZN600413S PZN600421S PZN600332S PZN600070S PZN600172S PZN600173S PZN600142S PZN600433S PZN600048S PZN600108S PZN600104S PZN600056S PZN600125S PZN600386S PZN600051S PZN600265S PZN600217S PZN600267S PZN600345S PZN600346S PZN600231S PZN600232S PZN600321S PZN600223S PZN600339S PZN600229S PZN600230S PZN600305S PZN600306S PZN600322S PZN600323S PZN600235S PZN600369S PZN600245S PZN600347S PZN600406S PZN600228S PZN600432S PZN600156S PZN600157S PZN600158S PZN600159S PZN600161S PZN600163S PZN600165S PZN600218S PZN600220S PZN600221S PZN600222S PZN600198S PZN600360S PZN600238S PZN600338S PZN600240S PZN600224S PZN600226S PZN600367S PZN600390S PZN600377S PZN600378S PZN600393S PZN600394S PZN600160S PZN600162S PZN600355S PZN600356S PZN600357S PZN600358S PZN600204S PZN600205S PZN600371S PZN600395S PZN600469S PZN600387S PZN600264S PZN600342S PZN600628S PZN600629S PZN600233S PZN600368S PZN600243S PZN600244S PZN600353S PZN600382S PZN600314S PZN600315S PZN600319S PZN600384S PZN600416S PZN600192S PZN600193S PZN600311S PZN600417S PZN600443S PZN600194S PZN600309S PZN600310S PZN600124S PZN600126S PZN600289S PZN600344S PZN600343S PZN600373S PZN600178S PZN600179S PZN600242S PZN600376S PZN600089S and PZN600449S.

Cardiovascular Devices

3

Yes

No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.

Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation.