Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL) |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S096 |
Date Received | 12/11/2017 |
Decision Date | 03/05/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for an alternate contract sterilizer site located at Synergy Heath Ireland Ltd, IDA Business & Technology Park, Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland. To perform as an alternate ethylene oxide sterilization vendor for the GRAFTMASTER Coronary Stent Graft System, MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System, XIENCE V and Nano Everolimus Eluting Coronary Stent System, and XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL). |
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