PMA P980001S027
- Device
- NIR PREMOUNTED STENT DELIVERY SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S027
- Decision date
- 2000-12-27
- Approval order statement
- ELIMINATION OF THE CREEP TEST FOR ASSESSING PACKAGE SEAL INTEGRITY.
Current openFDA PMA Record
- Device
- NIR PREMOUNTED STENT DELIVERY SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S027
- Decision date
- 2000-12-27
- Decision code
- OK30
- Date received
- 2000-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF THE CREEP TEST FOR ASSESSING PACKAGE SEAL INTEGRITY.