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 | S022 |
Date Received | 09/27/2013 |
Decision Date | 10/24/2013 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF A PROCESS CHANGE FOR STRETCHING AND NECKING A PTFE TUBE USED IN THE MANUFACTURE OF THE DELIVERY SYSTEM. |
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