|Trade Name||MODEL 5019 HV SPLITTER/ADAPTOR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||transvenous,steroid eluting,quadripolar,active fixation, pace/sense ventricular lead|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations; 2) an additional supplier for extruded tubing; transfer of incoming inspection location for various components; 3) modifications to a controlled environment; and 4)an alternate supplier of a silicone component.