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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 NameMYCARELINK PATIENT MONITOR, DEVICE DATA MANAGEMENT APPLICATION, APPLICATION SOFTWARE
Classification Namepulse generator, permanent, implantable
ApplicantMEDTRONIC, INC.
PMA NumberP890003
Supplement NumberS285
Date Received08/23/2013
Decision Date02/14/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for updates to the medtronic mycarelink patient monitor model 24950, 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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