|Trade Name||BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| 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.