PMA P900043S022
- Device
- Crossflex Lc Balloon Expandable Stent (angled End/square End
- Applicant
- CORDIS CORP.
- PMA number
- P900043
- Supplement
- S022
- Decision date
- 2000-03-02
Current openFDA PMA Record
- Device
- CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S022
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2000-03-02
- Decision code
- APPR
- Date received
- 2000-01-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the manufacturing process to form balloon shoulders at the distal and proximal ends of the stent.