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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 NumberS022
Date Received03/10/2011
Decision Date09/16/2011
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a 200 mm length stent and a new delivery system. The device, as modified, will be marketed under the trade name bard lifestent solo vascular stent system and is intended to improve luminal diameter in the treatment of symptomatic denovo or restenotic lesions up to 240 mm in length in native superficial femoral artery (sfa) and/or proximal popliteal arteries with reference vessel diameters ranging from 4. 0 - 6. 5 mm.
Post-Approval StudyShow Report Schedule and Study Progress
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