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 | ZILVER VASCULAR STENT |
Generic Name | STENT, ILIAC |
Applicant | Cook Ireland, Ltd. O'Halloran Road National Technology Park Limerick |
PMA Number | P050017 |
Supplement Number | S014 |
Date Received | 11/18/2016 |
Decision Date | 12/16/2016 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for additional quality control inspections. |
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