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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.
 
DeviceMEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
Classification Namestent, renal
Generic Namestent, renal
Applicant
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 
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