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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 NameINSYNC/INSYNC III CRT-IPGS, MODEL 8040/8042
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS019
Date Received12/09/2005
Decision Date05/12/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
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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