S.M.A.R.T. CONTROL Nitinol Stent System

Yes

Implant-endovascular-therapeutic

Catalog Numbers: C06020ML, C06020SL, C06030ML, C06030SL, C06040ML, C06040SL, C06060ML, C06060SL, C06080ML, C06080SL, C06100ML, C06100SL, C07020ML, C07020SL, C07030ML, C07030SL, C07040ML, C07040SL, C07060ML, C07060SL, C07080ML, C07080SL, C07100ML, C07100SL, C08020ML, C08020SL, C08030ML, C08030SL, C08040ML, C08040SL, C08060ML, C08060SL, C08080ML, C08080SL, C08100ML, C08100SL, C09020ML, C09020SL, C09030ML, C09030SL, C09040ML, C09040SL, C09060ML, C09060SL, C10020ML, C10020SL, C10030ML, C10030SL, C10040ML, C10040SL, C10060ML, C10060SL.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.

S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T.¿ CONTROL¿ in the logo/description. All unexpired lots from 15112447 through 15525516.

See letter | from 15112447 through 15525516

MD: Biliary/peripheral artery stent

C06060SV, C06080SV, C06100SV, C07040SV, C07060SV, C7080SV, C08060SV, C08080SV, C09040SV, C09060SV, C09080SV, C10040SV, C10060SV, C10080SV, C12040MV | See list

MD: Biliary/peripheral artery stent; Iliac artery stent

Model Catalog: C10040SL (Lot serial: 13339106); Model Catalog: C10040SL (Lot serial: 13327582); Model Catalog: C10040SL (Lot serial: 13326414)

SMART CONTROL NITINOL STENT SYSTEM