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 | MULTI-LINK RX PENTA CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S036 |
Date Received | 08/07/2001 |
Decision Date | 01/14/2002 |
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 AN INDICATION TO USE THE 3.0 MM TO 4.0 MM PENTA(TM) OTW AND TX FOR THE TREATMENT OF SVG LESIONS. THE MULTI-LINK RX PENTA AND MULTI-LINK OTW PENTA CORONARY STENT SYSTEM WILL INCLUDE THE FOLLOWING INDICATION: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENC EVESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM; 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <=35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM; AND 3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 2.5 MM AND 2.75 MM STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE. THE 33 MM AND 38 MM LENGTH STENTS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTW WITH LESIONS IN SAPHENOUS BEIN BYPASS GRAFTS. |
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