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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 NumberS229
Date Received12/19/2013
Decision Date02/27/2014
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software changes to the mycarelink patient monitor m2. 5 model 24950 with model 24955 rf head which supports the devices and medtronic¿s reveal insertable cardiac monitors models 9529, 9528 and lnq11. The mycarelink patient monitor is indicated for transmission of implantable device data to the carelink network for the clinic to review.
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