GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
FDA premarket approval P970035/S006 · decided 1999-04-27
Approval details
- PMA number
- P970035
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 1998-09-21
- Decision date
- 1999-04-27
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Approval for the 5-year post-approval study protocol for the Micro Stent(R) II and GFX(TM) Over-the-Wire Coronary Stent Systems.
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