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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.
Classification Nameimplantable cardioverter defibrillator (non-crt)
PMA NumberP980016
Supplement NumberS408
Date Received04/08/2013
Decision Date05/03/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a specific acceptance criterion to allow delamination for the lower wire bond pad on the u31 fet; 2) two process adjustment changes for the integrated circuit at medtronic supplier 3) the implementation of additional tooling for the case liner assembly manufacturing process; 4) a change to the hybrid cd surge manufacturing test software; 5) three changes including the implementation of a burn-in oven for the recovery and final voltage measurements steps for the batteries of the subject devices, 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; and 6) the implementation of additional laser welders to increase manufacturing capacity.