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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 NameCONSULTA CRT-P; SYNCRA CRT-P
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantMEDTRONIC, INC.
PMA NumberP010015
Supplement NumberS220
Date Received09/17/2013
Decision Date10/17/2013
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for molded silicone desiccant components.
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