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 | RX HERCULINK ELITE RENAL STENT SYSTEM |
Generic Name | STENT, RENAL |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P110001 |
Supplement Number | S009 |
Date Received | 08/02/2012 |
Decision Date | 10/09/2012 |
Product Code |
NIN |
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 ABBOTT VASCULAR CARDIAC THERAPIES IN CLONMEL, IRELAND. |
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