Stent, Renal
Basic Information
- Device Name
- Stent, Renal
- Trade Name
- MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
- PMA Number
- P020007
- Device Class
- FDA Class 3
- Product Code
- NIN
- Generic Name
- STENT, RENAL
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 18, 2002
- Date Received
- February 15, 2002
- Expedited Review
- Y
- Docket Number
- 03M-0487
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIN | Stent, Renal | FDA class 3 | Unknown |