|Trade Name||VENTAK P2 LEADS AND ACCESSORIES|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.