| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM |
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| Generic Name | STENT, RENAL |
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| Applicant | Medtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403 |
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| PMA Number | P020007 |
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| Date Received | 02/15/2002 |
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| Decision Date | 12/18/2002 |
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Withdrawal Date
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06/09/2008 |
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| Product Code |
NIN |
| Docket Number | 03M-0487 |
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| Notice Date | 10/28/2003 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 |
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