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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 CRT-D 8750, PARADYM RF CRT-D 9750
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantSORIN GROUP ITALIA S.R.L.
PMA NumberP060027
Supplement NumberS061
Date Received03/18/2014
Decision Date04/17/2014
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 design changes to the setscrews and torque screwdriver used in connecting the leads to implantable defibrillators.
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