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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTRACOIL PERIPHERAL STENT
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantMEDTRONIC VASCULAR INC
3033 Campus Drive
Plymouth, MN 55441
PMA NumberP000033
Supplement NumberS001
Date Received01/16/2004
Decision Date02/13/2004
Withdrawal Date 03/30/2018
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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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