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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 NameJEWEL AF, GEM III AT FAMILY OF ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardoverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980050
Supplement NumberS020
Date Received12/09/2005
Decision Date05/12/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic model 2091 wb wireless pc card for use with medtronic model 9986 desktop/boss (sw version 1. 5) for the medtronic carelink programmer (model 2090) for all medtronic and vitatron pacemaker and icd models.
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