PMA P970061S005
- Device
- SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S005
- Decision date
- 1999-02-11
- Approval order statement
- Approval for a Single-Operator Exchange (SOE) Delivery System for the SCIMED(R) RADIUS(TM) Stent. The device, as modified, will be marketed under the trade name SCIMED(R) RADUS(TM) Coronary Stent with Single-Operator Exchange (SOE) Delivery System and is indicated for use in pateitns with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diameter ranging from 2.75 to 4.25mm and is intended to improve coronary luminal diameter.
Current openFDA PMA Record
- Device
- SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S005
- Decision date
- 1999-02-11
- Decision code
- APPR
- Date received
- 1998-09-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a Single-Operator Exchange (SOE) Delivery System for the SCIMED(R) RADIUS(TM) Stent. The device, as modified, will be marketed under the trade name SCIMED(R) RADUS(TM) Coronary Stent with Single-Operator Exchange (SOE) Delivery System and is indicated for use in pateitns with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length