PMA P970035S015
- Device
- S670 RAPID EXCHANGE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S015
- Product code
- MAF
- Decision date
- 1999-11-23
- Generic name
- STENT, CORONARY
- Approval order statement
- The device is indicated for improving coronary luminal diameter in patients with symptomatic 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. The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressue during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone PTCA perfusion catheter.
Current openFDA PMA Record
- Device
- S670 RAPID EXCHANGE CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P970035
- Supplement
- S015
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-11-23
- Decision code
- APPR
- Date received
- 1999-04-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length