PMA P980001S016
- Device
- NIR(TM) PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S016
- Decision date
- 2000-02-25
- Approval order statement
- The 30-day notice requested to increase the tolerance allowed in the stent overlap to markerband placement by 0.25 mm (from 0.25mm to 0.50mm)
Current openFDA PMA Record
- Device
- NIR(TM) PREMOUNTED STENT SYSTEMS
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S016
- Decision date
- 2000-02-25
- Decision code
- OK30
- Date received
- 2000-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day notice requested to increase the tolerance allowed in the stent overlap to markerband placement by 0.25 mm (from 0.25mm to 0.50mm)