- Device
- CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S019
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2000-04-06
- Decision code
- APPR
- Date received
- 1999-11-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of the addition of the abrupt and threatened closure indication for the Cross flex LC Balloon Expandable Stent with over-the-wire Delivery System.