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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
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS025
Date Received10/17/2006
Decision Date11/15/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data.
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