|Trade Name||INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Generic Name||cardiac resynchronization therapy pacemaker (crt-p)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) replacement of the polymide tubing with polyetheretherktone (peek) tubing on the pulse generator pg header assemblies; 2) the use of a combination of natural and colorized peek to assist manufacturing operators; and 3) the addition of an extra plasma cleaning step to ensure that the bond formed between the medical adhesive applied to the base of the wire and the peek insulation is strong.