|
Device | SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S001 |
Date Received | 08/10/1998 |
Decision Date | 02/04/1999 |
Withdrawal Date
|
07/17/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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 <30mm) with reference vessel diamter ranging from 2.75 to 4.25 mm and is intended to improve coronary luminial diameter. |