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 | S003 |
Date Received | 07/10/2008 |
Decision Date | 02/03/2009 |
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 COOK IRELAND, LTD., LIMERICK, IRELAND FOR MANUFACTURING AND FINAL MANUFACTURING TO INCLUDE LABELING AND PACKAGING, AND FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD., TULLAMORE, IRELAND. |
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