PMA P980001S020
- Device
- NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S020
- Decision date
- 2000-06-13
- Approval order statement
- CHANGE IN MANUFACTURING PROCESS TO REMOVE TWO INSPECTION STEPS FOR MARKERBAND PLACEMENT ON THE NIR(TM) W/SOX(TM) PREMOUNTED STENT DELIVERY SYSTEM.
Current openFDA PMA Record
- Device
- NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S020
- Decision date
- 2000-06-13
- Decision code
- OK30
- Date received
- 2000-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN MANUFACTURING PROCESS TO REMOVE TWO INSPECTION STEPS FOR MARKERBAND PLACEMENT ON THE NIR(TM) W/SOX(TM) PREMOUNTED STENT DELIVERY SYSTEM.