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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 NameSMARTMAGNET(TM)
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS013
Date Received08/30/2000
Decision Date02/22/2001
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 9322 smartmagnet(tm). The device, as modified, will be marketed under the trade name smartmagnet(tm) and is indicated for keeping medtronic icds from delivering inappropriate therapy, such as shocks, to patients during surgical procedures that require cautery or other electrically noisy devices.
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