PMA P970061S006
- Device
- SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S006
- Decision date
- 1999-06-30
- Approval order statement
- Approval for the 31 mm SCIMED(R) RADIUS(TM) Coronary Stent with Over-The-Wire (OTW) and Single-Operator (SOE) Delivery Systems.
Current openFDA PMA Record
- Device
- SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S006
- Decision date
- 1999-06-30
- Decision code
- APPR
- Date received
- 1998-11-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the 31 mm SCIMED(R) RADIUS(TM) Coronary Stent with Over-The-Wire (OTW) and Single-Operator (SOE) Delivery Systems.