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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.
 
DeviceCARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE
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 NumberS179
Date Received12/04/2009
Decision Date01/09/2012
Product Code
OSR[ Registered Establishments with OSR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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