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 | S012 |
Date Received | 03/26/2013 |
Decision Date | 06/06/2013 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00896337
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Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS. |
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