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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, GEMM III AT FAMILY OF ICD'S
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardoverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980050
Supplement NumberS027
Date Received03/09/2007
Decision Date05/03/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software enhancements to the medtronic model 9986 desktop boss (version 1. 6) for the medtronic model 2090 carelink programmer for all currently approved medtronic and vitatron pacemaker and icd models.
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