|Trade Name||ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||dual chamber icds|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes including: 1) moving the accelerometer testing operation earlier in the manufacturing flow; 2) moving the patient alert resting operation earlier in the manufacturing process; and 3) performing the medical adhesive curing and device pre-heat process in a single oven.