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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINSYNC 8040 DEVICES
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS014
Date Received08/23/2004
Decision Date09/15/2004
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL TO UPDATE THE LONGEVITY PROJECTIONS FOR THE MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847 SOFTWARE FOR 7968-I THERA DR DEVICE AND MODEL 9980 SOFTWARE FOR THE INSYNC 8040 DEVICE.
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