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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINTRA COIL SELF-EXPANDING PERIPHERAL STENT
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
MEDTRONIC VASCULAR INC
3033 campus drive
plymouth, MN 55441
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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