PMA P900043S015
- Device
- Cross Flex Lc Balloon-expandable Stent With Over T
- Applicant
- CORDIS CORP.
- PMA number
- P900043
- Supplement
- S015
- Decision date
- 1999-09-14
Current openFDA PMA Record
- Device
- CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S015
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1999-09-14
- Decision code
- APPR
- Date received
- 1999-03-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to market a new stent system. The device is indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 to 4.0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present.