PMA P980001S019
- Device
- NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S019
- Decision date
- 2000-05-30
- Approval order statement
- MINOR MODIFICATION TO AN IN-PROCESS MANUFACTURING STEP FOR THE BALLOON COMPONENT OF THE NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM.
Current openFDA PMA Record
- Device
- NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S019
- Decision date
- 2000-05-30
- Decision code
- OK30
- Date received
- 2000-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MINOR MODIFICATION TO AN IN-PROCESS MANUFACTURING STEP FOR THE BALLOON COMPONENT OF THE NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM.