Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SCIMEN RADIUS STENT WITH MONORAIL DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S014 |
Date Received | 01/08/2002 |
Decision Date | 02/15/2002 |
Withdrawal Date
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07/17/2007 |
Product Code |
MAF |
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 MINOR LABELING CHANGES TO THE PACKAGE LABELING AND THE "DIRECTIONS FOR USE" MANUAL FOR THE RADIUS CORONARY STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCIMED RADIUS STENT WITH MONORAIL DELIVERY SYSTEM AND IS INDICATED FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY AND SAPHENOUS VEIN BYPASS GRAFT LESIONS (LENGTH < 30 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.75 TO 4.25 MM AND IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER. |
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