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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 DR/GEM II DR/GEM II VR
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS018
Date Received04/17/2001
Decision Date05/14/2001
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the general use indication for implantable cardioverter defibrillator models micro jewel 7221, micro jewel ii 7223, gem dr 7271, gem ii dr 7273 and gem ii vr 7229 and are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
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