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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC CRDM
PMA NumberP010031
Supplement NumberS354
Date Received02/06/2013
Decision Date03/07/2013
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Three changes including the implementation of a burn-in oven for the recovery and final voltage measurements steps for the batteries of the subject crt-d systems, corrections to the subject systems¿ battery test specification to align with measurement system capabilities, and consolidation of measurement steps within the burn in test process.
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