SynCardia Systems Inc.

S/N 5002  UDI (01)00858000003121(21)5002 S/N 5005  UDI (01)00858000003121(21)5005 S/N 5008  UDI (01)00858000003121(21)5008 S/N 5009  UDI (01)00858000003121(21)5009 S/N 5010  UDI (01)00858000003121(21)5010

Cardiovascular Devices

3

Yes

US distribution to Virginia and Arizona.

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

Serial # Lot#  00067 11/12  00071 11/12  00073 11/12  00076 11/12  00079 11/12  00085 11/12  00086 11/12  00087 11/12  00089 28/12  00091 28/12  00092 28/12   00093 28/12  00094 28/12  00095 28/12  00098 28/12  00099 28/12  00101 28/12  00102 28/12  00103 28/12  00104 28/12  00105 28/12  00106 28/12  00107 28/12  00108 28/12  00109 28/12  00110 28/12  00111 28/12  00112 28/12  00113 28/12  00114 28/12  00115 28/12  00116 28/12  00117 28/12  00118 28/12  00119 28/12  00120 28/12  00121 28/12  00122 28/12  00123 28/12  00124 28/12  00125 28/12  00126 28/12  00127 28/12  00128 28/12  00129 28/12  00130 28/12  00131 28/12  00132 28/12  00133 28/12  00134 28/12  00135 28/12  00136 28/12  00137 28/12  00138 28/12  00139 28/12  00140 28/12  00141 28/12  00142 28/12  00143 28/12  00144 28/12  00145 28/12  00146 28/12  00147 28/12  00148 28/12  00068 11/12  00069 11/12  00070 11/12  00072 11/12 00075 11/12  00077 11/12  00078 11/12  00080 11/12  00081 11/12  00082 11/12  00083 11/12  00084 11/12  00088 11/12  00090 28/12  00096 28/12  00097 28/12  00100 28/12

Cardiovascular Devices

3

Yes

Worldwide Distribution -- US (nationwide)

Companion External Battery, Part Number: 293001-001 || The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

Part Number: 595000-001  Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial # 85979-013 85979 031479 4506 85979-022 85979 031479 4506 85977-033 85977 031333 4507  85976-020 85976 031041 4514  85976-010 85976 030944 4517 85976-014 85976 030944 4517 85979-014 85979 031479 4517 85979-021 85979 031479 4517 85976-039 85976 031074 4521 85977-001 85977 031074 4521 85978-034 85978 031823 4521 85978-040 85978 031823 4521 85977-020 85977 031333 4542 85977-032 85977 031333 4542 85979-005 85979 031452 4546 85979-012 85979 031452 4546 85979-018 85979 031479 4559 85979-024 85979 031479 4559 85976-016 85976 031041 4573 85976-026 85976 031041 4573 85977-005 85977 031140 4592 85977-008 85977 031140 4592 85977-021 85977 031333 4593 85977-025 85977 031333 4593 85979-004 85979 031452 4635 85979-007 85979 031452 4635 85979-033 85979 031823 4642 85979-026 85979 031479 4645 85979-028 85979 031479 4645 85979-017 85979 031479 4653 85979-019 85979 031479 4653 85977-026 85977 031333 4661 85978-026 85978 031623 4677 85978-032 85978 031623 4677 85977-019 85977 031405 4681  85978-018 85978 031623 4700 85978-022 85978 031623 4700 85977-012 85977 031255 4720  85978-020 85978 031623 4722 85978-025 85978 031623 4722 85976-006 85976 031041 4732  85977-006 85977 031140 4756 85978-035 85978 031823 4763  85976-001 85976 030944 4782 85976-003 85976 030944 4782 85976-037 85976 031057 4784 85976-040 85976 031057 4784 85976-030 85976 031074 4785 85976-036 85976 031074 4785 85976-022 85976 031074 4788 85976-024 85976 031074 4788 85976-015 85976 031074 4790 85976-038 85976 031074 4790 85976-023 85976 031074 4791 85976-032 85976 031074 4791 85977-015 85977 031333 4792 85977-028 85977 031333 4792 85977-030 85977 031333 4793  85977-013 85977 031333 4794 85977-023 85977 031333 4794 85977-016 85977 031333 4796 85977-031 85977 031333 4796 85977-010 85977 031405 4797 85977-011 85977 031405 4797 85977-009 85977 031405 4798 85977-037 85977 031406 4798 85977-003 85977 031405 4799 85977-034 85977 031405 4799 85977-035 85977 031406 4800 85977-036 85977 031406 4800 85978-037 85978 031823 4800 85977-039 85977 031406 4801 85977-040 85977 031406 4801 85979-011 85979 031452 4802 85978-002 85978 031487 4806 85978-004 85978 031487 4806 85978-003 85978 031487 4808 85978-006 85978 031487 4808 85979-029 85979 031541 4809 85979-031 85979 031541 4809 85978-010 85978 031541 4810 85979-038 85979 031541 4810 85978-009 85978 031541 4811 85979-034 85979 031541 4811 85979-032 85979 031541 4812 85979-035 85979 031541 4812 85978-008 85978 031541 4813 85979-036 85979 031541 4813 85978-016 85978 031623 4814 85978-021 85978 031623 4814 85978-013 85978 031623 4815 85978-024 85978 031623 4815 85978-027 85978 031623 4817 85978-030 85978 031623 4817 85978-017 85978 031623 4818 85978-029 85978 031623 4818

Cardiovascular Devices

3

Yes

Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France.

Temporary Total Artificial Heart (TAH-t) with Freedom Driver System || REF 595000-001 || Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.