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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, renal
Generic Namestent, renal
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP020007
Date Received02/15/2002
Decision Date12/18/2002
Withdrawal Date 06/09/2008
Product Code
NIN[ Registered Establishments with NIN ]
Docket Number 03M-0487
Notice Date 10/28/2003
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the medtronic ave bridge extra support over-the-wire (otw) renal stent system. The device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal or failed percutaneous transluminal renal angioplasty (ptra) of a de novo lesion (<=15 mm in length) located within 10 mm of the aortorenal border and with a reference vessel diameter of 5. 0 to 7. 0 mm. Sub-optimal or failed ptra include any of the following: visible evidence of a residual stenosis >=50% after optimal ptra, visible evidence of intimal dissection >6 mm, or peak systolic trans-stenotic gradient of >=20 mm hg or a mean of >=10 mm hg.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001