PMA P980001S026
- Device
- NIR(TM) PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S026
- Decision date
- 2000-11-08
- Approval order statement
- MANUFACTURING CHANGE TO INCLUDE THE USE OF SCRAPPED MATERIAL IN FINAL FUNCTIONAL TESTING TO OBTAIN TRENDING DATA FOR SOX SECUREMENT.
Current openFDA PMA Record
- Device
- NIR(TM) PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S026
- Decision date
- 2000-11-08
- Decision code
- OK30
- Date received
- 2000-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING CHANGE TO INCLUDE THE USE OF SCRAPPED MATERIAL IN FINAL FUNCTIONAL TESTING TO OBTAIN TRENDING DATA FOR SOX SECUREMENT.