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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.
 
DeviceCOMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP110040
Supplement NumberS005
Date Received03/04/2014
Decision Date04/03/2014
Withdrawal Date 05/23/2019
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS.
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