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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 8040 DEVICE, INSYNC III 8042.8044 DEVICES
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS024
Date Received07/21/2006
Decision Date08/31/2006
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 longevity projection update sw v1. 1.
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