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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 NamePermanent defibrillator electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS077
Date Received06/20/2011
Decision Date08/05/2011
Product Code NVY 
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 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.
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