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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBARD LIFESTENT VASCULAR STENT SYSTEMS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBard Peripheral Vascular, Inc.
1415 W. 3rd St.
Tempe, AZ 85281
PMA NumberP070014
Supplement NumberS008
Date Received12/23/2009
Decision Date06/09/2010
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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