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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 NameGEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameautomatic implantable cardioverter/defibrillator
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS041
Date Received12/17/1999
Decision Date03/02/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the circuitry of the medtronic model 7227 gem implantable cardioverter defibrillator.
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