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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, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
PMA NumberP060027
Supplement NumberS015
Date Received09/29/2009
Decision Date04/07/2010
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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 and manufacturing changes and labeling and programmer software changes to the ovatio vr model 6250, dr model 6550 and crt-d model 6750. The device, as modified, will be marketed under the trade name paradym vr model 8250 and paradym dr model 8550 with smartview 2. 18ug1 and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: survival of at least one episode of cardiac arrest manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent poorly tolerated sustained ventricular tachycardia.
Approval Order Approval Order