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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 III AT 7276
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardoverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980050
Supplement NumberS022
Date Received02/21/2006
Decision Date04/21/2006
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 the sessionsync feature as part of an enhancement to model 9986 desktop / baseline operating system software (boss) versions 1. 3. 8/1. 5 for the 2090 carelink programmer. Sessionsync allows data transfer between the model 2090 carelink programmer and the customer's paceart system (a data management system).
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