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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.
Trade NamePARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
PMA NumberP060027
Supplement NumberS053
Date Received08/21/2013
Decision Date03/06/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for: 1) a firmware patch for the implantable device with the microprocessor (up) v4b; 2) a new firmware version for the up v4c and v4d; 3) the hardware modifications for the implantable devices; 4) the updates/ modifications for the programmer application software; and 5) the updates/ modifications for the remote monitoring system (rms).
Approval Order Approval Order