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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceVICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS108
Date Received08/30/2005
Decision Date12/07/2005
Product Code KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VICTORY PULSE GENERATOR MODELS XL DR 5816, DR 5810 AND SR 5610.
  We welcome your comments and feedback about Devices@FDA.
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