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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.
 
Trade NameMEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM
Classification Namestent, renal
Generic Namerenal stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP020007
Supplement NumberS001
Date Received04/22/2003
Decision Date05/15/2003
Product Code
NIN[ Registered Establishments with NIN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study for the device.
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