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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 AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP020007
Supplement NumberS001
Date Received04/22/2003
Decision Date05/15/2003
Withdrawal Date06/09/2008
Product Code NIN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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