|Trade Name||STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at sterigenics germany gmbh, wiesbaden, germany as an alternate sterilization facility. 30-day notices (135 day supplement was not required) summary of pma originals & supplements approved originals: supplements: summary of pma originals under review total under review: total active: total on hold: number greater than 180 days: summary of pma supplements under review total under review: total active: total on hold: number greater than 180 days: summary of all pma submissions received originals: supplements: summary of pma supplement pma approval/denial decision times number of approvals: number of denials: average days fr receipt to decision (total time): fda time: days mfr time: days.