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 | PARADYM CRT-D MODEL 8750 |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P060027 |
Supplement Number | S015 |
Date Received | 09/24/2009 |
Decision Date | 04/07/2010 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE PARADYM VR MODEL 8250 AND DR MODEL 8550 WITH SMARTVIEW 2.18UG1 PROGRAMMER SOFTWARE AND THE PARADYM CRT-D MODEL 8750 WITH HARDWARE ANDMANUFACTURING CHANGES AND LABELING AND PROGRAMMER SOFTWARE CHANGES TO THE OVATIO VRMODEL 6250, DR MODEL 6550 AND CRT-D MODEL 6750. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME PARADYM VR MODEL 8250 AND PARADYM DR MODEL 8550 WITHSMARTVIEW 2.18UG1 AND IS INDICATED FOR USE IN PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIACDEATH DUE TO VENTRICULAR TACHYARRHYTHMIAS AND WHO HAVE EXPERIENCED ONE OF THE FOLLOWINGSITUATIONS: SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST MANIFESTED BY THE LOSS OFCONSCIOUSNESS) DUE TO VENTRICULAR TACHYARRHYTHMIA, RECURRENT POORLY TOLERATED SUSTAINEDVENTRICULAR TACHYCARDIA. |
Approval Order | Approval Order |
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