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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.
 
DeviceINTRACOIL PERIPHERAL STENT
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
MEDTRONIC VASCULAR INC
3033 campus drive
plymouth, MN 55441
PMA NumberP000033
Supplement NumberS001
Date Received01/16/2004
Decision Date02/13/2004
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing process to propose an alternate wire polishing vendor for the nitinol wire polishing process.
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