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. |
|
Device | ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S031 |
Date Received | 04/11/2001 |
Decision Date | 06/05/2001 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A NEW INDICATION FOR THE ACS MULTI-LINK RX AND OTW D, TRISTAR, ULTR TETRA CORONARY STENT SYSTEMS AND ACS MULTI-LINK. STENT AND THE FOUR DELIVERY SYSTEMS. THE NEW ADDITIONAL INDICATION FOR THESE DEVICES IS FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH = 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM. |
|
|