|Trade Name||CONSULTA CRT-P, SYNCRA CRT-P|
|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 |
Add additional models that were not included in a previously approved 30-day notice regarding the implementation of material analysis and qualification system (maqs) for incoming inspection.