PMA P970061S004
- Device
- SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S004
- Product code
- MAF
- Decision date
- 1998-09-25
- Generic name
- STENT, CORONARY
- Approval order statement
- Approval for revisions to the Instructions for Use.
Current openFDA PMA Record
- Device
- SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S004
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 1998-09-25
- Decision code
- APPR
- Date received
- 1998-09-04
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the Instructions for Use.