PMA P970035S006
- Device
- GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S006
- Product code
- MAF
- Decision date
- 1999-04-27
- Generic name
- STENT, CORONARY
- Approval order 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.
Current openFDA PMA Record
- Device
- GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S006
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-04-27
- Decision code
- APPR
- Date received
- 1998-09-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order 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.