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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 (ZL101),PARADYM RF CRT-D9750 (ZL102)
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantSORIN GROUP- CRM
PMA NumberP060027
Supplement NumberS063
Date Received04/10/2014
Decision Date04/21/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to in-process verifications on the electronic assembly line.
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