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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBARD LIFESTENT VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Nameperipheral(sfa) stent system
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP070014
Supplement NumberS002
Date Received06/18/2009
Decision Date07/17/2009
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the quality control inspection testing on post-sterile devices.
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