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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.
 
DeviceDURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS
Generic NamePermanent defibrillator electrodes
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP950022
Supplement NumberS075
Date Received10/21/2010
Decision Date12/06/2010
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MOLDED CONNECTOR SUBASSEMBLY FOR IMPROVED MANUFACTURABILITY AND REDUCED COST FOR THE DURATA SJ4 AND DF4 HIGH VOLTAGE LEADS. CHANGES INCLUDE MINOR DESIGN, MATERIAL, AND MANUFACTURING PROCESS CHANGES. ADDITIONALLY, THE CURRENT APPROVED SUPPLIER, ACCELLENT, WILL BE PERFORMING ALL MANUFACTURING OPERATIONS RELATED TO THE MOLDED CONNECTOR SUBASSEMBLY.
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