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Device | BARD LIFESTENT VASCULAR STENT SYSTEMS |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S008 |
Date Received | 12/23/2009 |
Decision Date | 06/09/2010 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MOVING A MANUFACTURING PROCESS AND ASSOCIATED EQUIPMENT FROM A SUPPLIER TO INTERNAL MANUFACTURING AT BARD ANGIOMED GMBH & CO. MEDIZINTCHNIK KG (ANGIOMED) FOR THE DELIVERY SYSTEM TIP CHAMFERING MANUFACTURING. |