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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 7271 GEM DR ICD
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP980016
Supplement NumberS010
Date Received10/21/1999
Decision Date12/23/1999
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for low power hybrid circuitry changes which will improve the patient alert drive transistors, the charge pump circuit and the manufacturing process.
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