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 Sierra Everolimus Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110019 |
Supplement Number | S114 |
Date Received | 11/16/2020 |
Decision Date | 12/16/2020 |
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 Manufacturing site located at Abbott Vascular, 26531 Ynez Road, Temecula, CA 92591, for finished product manufacturing, catheter manufacturing, and labeling. |
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