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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 ICDS AND CRT-D DEVICES
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantELA MEDICAL, INC.
PMA NumberP060027
Supplement NumberS029
Date Received12/21/2010
Decision Date02/10/2011
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the changes of the transformer (t413), opto wedge (g309), and desiccant (j907) for the paradym icd and crt-d models 8250, 8550, and 8750.
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