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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 NameMEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameautomatic implantable cardioverter/defibrillator
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS038
Date Received05/26/1999
Decision Date06/16/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise the circuitry of the high power hybrids used in the model 7227cx gem(tm) and the model 7273 gem(tm) ii dr implantable cardioverter defibrillators to correct the premature low battery problem.
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