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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 II CRT-IPG'S
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS021
Date Received02/14/2006
Decision Date03/31/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the medtronic model 9986 desktop/boss (software version 1. 5. 1) for the medtronic model 2090 carelink programmer for all medtronic pacemaker and icd models. It is to enhance internal.
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