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 | POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S204 |
Date Received | 10/20/2000 |
Decision Date | 03/02/2001 |
Reclassified Date
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10/08/2010 |
Product Codes |
DYG LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW CATHETER MODELS. THE DEVICES, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES POWERSAIL(TM) AND HIGHSAIL(TM) CORONARY DILATATION CATHETERS AND ARE INDICATED FOR: 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. 3) BALLOON DILATATION OF THE ACS MULTI-LINK(TM), ACS MULTI-LINK(TM), ACS MULTI-LINK DUET(TM), ACS MULTI-LINK TRISTAR(TM), MULTI-LINK TETRA(TM) OR ACS MULTI-LINK ULTRA(TM) STENTS AFTER IMPLANTATION. |
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