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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.
 
DeviceINDENTITY & IDENTITY ADX FAMILY OF DEVICES
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS150
Date Received06/20/2007
Decision Date07/12/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR USE OF THE CIRCUITRY USE DIN THE ANALOG CHIP IN THE VICTORY/ZEPHYR FAMILY OF DEVICES IN THE ANALOG CHIP USED IN THE IDENTITY AND IDENTITY ADX FAMILY OF DEVICES, AND FOR RESIZING THE SENSE AND IEGM GAIN CAPACITORS.
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