PMA P970061S008
- Device
- RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S008
- Decision date
- 2000-02-11
- Approval order statement
- Approval of the addition of two tensile strenght specifications for the pullwire assembly.
Current openFDA PMA Record
- Device
- RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S008
- Decision date
- 2000-02-11
- Decision code
- APPR
- Date received
- 2000-01-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of the addition of two tensile strenght specifications for the pullwire assembly.