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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 NameMODEL 2490A CARELINK MONITOR AND 2491 SOFTWARE
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS021
Date Received09/06/2001
Decision Date12/21/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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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