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 | ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S024 |
Date Received | 05/30/2000 |
Decision Date | 06/23/2000 |
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 INCLUSION OF THE SIX-MONTH CLINICAL TRIAL DATA FROM THE DUET STUDY IN THE INSTRUCTIONS FOR USE (IFU) FOR THE ACS MULTI-LINK RX AND OTW DUET(TM) CORONARY STENT SYSTEMS. |
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