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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.
 
DeviceMODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS021
Date Received09/06/2001
Decision Date12/21/2001
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 2490A CARELINK MONITOR WITH MODEL 2491 DDMA SERVER-RESIDENT SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 2490A CARELINK MONITOR AND IS INDICATED FOR USE IN THE TRANSFER OF PATIENT DATA FROM MEDTRONIC GEM II ICDS (GEM II VR MODEL 7229 AND GEM II DR MODEL 7273).
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