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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.
 
DeviceCONNECTOR SLEEVE ACCESSORY KIT
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS192
Date Received06/20/2011
Decision Date08/05/2011
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CONNECTOR SLEEVE ACCESSORY KIT MODEL EX3151. THE CONNECTOR SLEEVE IS INDICATED FOR USE WITH IS-4 AND DF-4 LEAD CONNECTORS TO FACILITATE THE CONNECTION TO A PACING SYSTEM ANALYZER AT THE TIME OF IMPLANT.
Post-Approval StudyShow Report Schedule and Study Progress
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