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 | EPIC VASCULAR SELF-EXPANDING STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | Boston Scientific Corp. Ballybrit Industrial Estate, Ballybrit Galway H91 Y |
PMA Number | P110035 |
Supplement Number | S036 |
Date Received | 06/15/2016 |
Decision Date | 08/11/2016 |
Product Code |
NIO |
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 | No |
Approval Order Statement Approval for a manufacturing site located at Boston Scientific, 2 Scimed Place, Maple Grove, Minnesota, for stent finishing, inspection, and cleaning. |
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