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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.
 
DeviceSYNCHRONY MODEL 2020T PULSE GENERATOR
Generic Nameimplantable pacemaker Pulse-generator
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS097
Date Received10/07/2003
Decision Date10/31/2003
Product Codes DTB DXY KRG 
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 MODIFICATION TO THE MODEL 3510 PROGRAMMER PLATFORM BY ADDING A VIDEO DISPLAY OUT PORT AND THE ADDITION OF A NEW VIDEO CABLE, MODEL 3134.
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