PMA P970035S011
- Device
- Gfx Sl Over-the-wire Coronary Stent System
- Applicant
- MEDTRONIC IRELAND
- PMA number
- P970035
- Supplement
- S011
- Decision date
- 1999-06-03
Current openFDA PMA Record
- Device
- GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S011
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-06-03
- Decision code
- APPR
- Date received
- 1998-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Medtronic AVE S540(TM) Over-The_Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (length