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 | RX CHASSIS I 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 | S203 |
Date Received | 10/17/2000 |
Decision Date | 01/11/2001 |
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 THE RX CHASSIS 1(TM) CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, IS INDICATED FOR A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OF BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. |
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