PMA P970035S014
- Device
- S670 OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S014
- Product code
- MAF
- Decision date
- 1999-11-16
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for the Medtronic AVE (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present.
Current openFDA PMA Record
- Device
- S670 OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S014
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-11-16
- Decision code
- APPR
- Date received
- 1999-04-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Medtronic AVE (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length