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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.
 
DeviceGEM MODEL 7227 ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP900061
Supplement NumberS056
Date Received03/27/2002
Decision Date04/16/2002
Product Code
LWS[ Registered Establishments with LWS ]
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 EXPANSION OF THE FUNCTIONALITY OF THE MODEL 2490A CARELINK MONITOR AND MODEL 2491 SOFTWARE, VERSION 1.0 TO INCLUDE THE GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR AND GEM III DR IMPLANTABLE CARDIOVETER DEFIBRILLATORS.
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