MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
FDA premarket approval P020007 · decided 2002-12-18
Approval details
- PMA number
- P020007
- Trade name
- MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Medtronic Vascular
- Date received
- 2002-02-15
- Decision date
- 2002-12-18
- Days to decision
- 306 days
- Decision code
- APWD
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Santa Rosa, CA
- 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 S
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