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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 NumberS028
Date Received08/13/2010
Decision Date09/08/2010
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the design changes for low voltage electronic hybrid module and interconnection flex circuit for paradym vr/dr and crt-d, models 8250, 8550, and 8750.
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