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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.
 
DeviceLIFESTENT VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 west 3rd st.
tempe, AZ 85281
PMA NumberP070014
Supplement NumberS025
Date Received09/21/2011
Decision Date11/21/2011
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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