MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM
FDA premarket approval P020007/S001 · decided 2003-05-15
Approval details
- PMA number
- P020007
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Medtronic Vascular
- Date received
- 2003-04-22
- Decision date
- 2003-05-15
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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