|Trade Name||SELUTE LEADS AND ACCESSORIES|
|Classification Name||permanent pacemaker electrode|
|Generic Name||alternate endocardial lead stabilizer component|
|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.