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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.
 
DeviceLIFE STENT 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 NumberS044
Date Received05/01/2014
Decision Date07/18/2014
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a smaller stent diameter (5mm) with an identical design/cut pattern to the current lifestent.
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