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 | LIFESTENT SOLO VASCULAR STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S032 |
Date Received | 04/06/2012 |
Decision Date | 05/25/2012 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR CHANGES TO THE DIVING SHEATH WITH PULL WIRE COMPONENT OF THE DELIVERY SYSTEM. |
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