PMA P980001S010
- Device
- NIR PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S010
- Decision date
- 1999-07-22
- Approval order statement
- The 30-Day Notice requested modification of the dimensions of two packaging components (packaging tube and balloon/stent protector) to allow for easier device removal.
Current openFDA PMA Record
- Device
- NIR PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S010
- Decision date
- 1999-07-22
- Decision code
- OK30
- Date received
- 1999-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested modification of the dimensions of two packaging components (packaging tube and balloon/stent protector) to allow for easier device removal.