PMA P900043S005
- Device
- PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S005
- Product code
- MAF
- Decision date
- 1997-03-13
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR CHANGES IN THE BALLOON FOLDING AND STENT CRIMPING MANUFACTURING PROCESS AND THE ADDITION OF A NEW STENT RETENTION TEST
Current openFDA PMA Record
- Device
- PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S005
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1997-03-13
- Decision code
- APPR
- Date received
- 1997-01-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES IN THE BALLOON FOLDING AND STENT CRIMPING MANUFACTURING PROCESS AND THE ADDITION OF A NEW STENT RETENTION TEST