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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.
 
DeviceCONSULTA CRT-P, SYNCRA CRT-P
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS215
Date Received08/23/2013
Decision Date02/14/2014
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for updates to the medtronic mycarelink patient monitor model24950, reader model 24955, and accessories, model 2491 device data management application (ddma) and application software sw026 to support medtronic¿s reveal linq insertable cardiac monitors (icm).
Approval Order Approval Order
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