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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.
 
DeviceMEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM
Generic NameStent, carotid
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP070012
Supplement NumberS001
Date Received02/04/2008
Decision Date03/06/2008
Withdrawal Date09/20/2013
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE BY THE VENDOR OF THE EXPONENT RX PACKAGING HEADER POUCH TO THE EQUIPMENT USED TO PRODUCE THE VENDOR-SUPPLIED SEALS.
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