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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINTRA COIL SELF-EXPANDING PERIPHERAL STENT
Classification Namestent, superficial femoral artery
Generic Namevascular stent
ApplicantEV3 INC
PMA NumberP000033
Date Received08/03/2000
Decision Date04/03/2002
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 02M-0235
Notice Date 05/24/2002
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the intracoil self-expanding peripheral stent. This device is indicated for improving peripheral luminal diameter in patients with symptomatic atherosclerotic disease due to stenotic lesions (length <= 15 cm) or occlusive lesions (length <= 12 cm) in femoropopliteal arteries, to the bifurcation of the tibial artery, with a reference vessel diameter of 3. 0 to 7. 8 mm.
Approval Order Approval Order
Supplements: S001 S002 
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