PMA P970061S001
- Device
- Scimed Radius Coronary Stent With Delivery System
- Applicant
- BOSTON SCIENTIFIC SCIMED, INC.
- PMA number
- P970061
- Supplement
- S001
- Decision date
- 1999-02-04
Current openFDA PMA Record
- Device
- SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P970061
- Supplement
- S001
- Decision date
- 1999-02-04
- Decision code
- APPR
- Date received
- 1998-08-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a modification ot the indications statement to include the treatment of saphenous vein graft lesions. The SCIMED RADIUS(TM) Coronary Stent (14 mm and 20 mm lengths) with Delivery System is indicated for use in patients with symptomaitc ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length