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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-D 9750 (ZL 102) AND INTENSIA CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantSORIN GROUP- CRM
PMA NumberP060027
Supplement NumberS075
Date Received02/24/2015
Decision Date03/19/2015
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices.
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