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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMYCARELINK PATIENT MONITOR
Classification Namepacemaker/icd/crt non-implanted components
Generic Namepacemaker/icd/crt non-implanted components
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP890003
Supplement NumberS307
Date Received03/28/2014
Decision Date05/29/2014
Product Code
OSR[ Registered Establishments with OSR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
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