|Trade Name||ATTAIN PERFORMA|
|Classification Name||drug eluting permanent left ventricular (lv) pacemaker electrode|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The following manufacturing changes: 1) the addition of an alternative testing system for electrode components; 2) use of factoryworks release 7. 9 manufacturing software; 3) a reduction in the exposure time during ethylene oxide half-cycle testing; 4) a reduction in the frequency of environmental monitoring testing in specific manufacturing areas; 5) an update to the maximum sterilization load profile temperature; and 6) use of factoryworks release 7. 11 manufacturing software.