PMA P980001S018
- Device
- NIR PREMOUNTED STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S018
- Decision date
- 2000-04-25
- Approval order statement
- Approval for an addition of a note to the Instructions for Use of the NIR Primo Premounted Stent System.
Current openFDA PMA Record
- Device
- NIR PREMOUNTED STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P980001
- Supplement
- S018
- Decision date
- 2000-04-25
- Decision code
- APPR
- Date received
- 2000-03-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an addition of a note to the Instructions for Use of the NIR Primo Premounted Stent System.