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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 NameCONCERTO INSYNC FAMILIES OF CRT-ICD'S
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS066
Date Received03/09/2007
Decision Date05/03/2007
Product Code
NIK[ Registered Establishments with NIK ]
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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