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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 SOLO VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Nameperipheral(sfa) stent system
ApplicantBARD PERIPHERAL VASCULAR, INC.
PMA NumberP070014
Supplement NumberS027
Date Received10/03/2011
Decision Date11/17/2011
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a smaller packaging configuration and minor labeling changes to accommodate the changes to the packaging.
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