PMA P970061S009
- Device
- BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S009
- Decision date
- 2000-08-22
- Approval order statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC/SCIMED, INC., PLYMOUTH, MINNESOTA 55442 AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA, WILLOWBROOK, ILLINOIS 60521.
Current openFDA PMA Record
- Device
- BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S009
- Decision date
- 2000-08-22
- Decision code
- APPR
- Date received
- 2000-07-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC/SCIMED, INC., PLYMOUTH, MINNESOTA 55442 AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT IBA, WILLOWBROOK, ILLINOIS 60521.