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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
4 avenue reaumur
clamart cedex 92140
PMA NumberP980049
Supplement NumberS050
Date Received09/24/2009
Decision Date04/07/2010
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Recalls CDRH Recalls
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