|Trade Name||CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12|
|Classification Name||device, removal, pacemaker electrode, percutaneous|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) removal of bioburden testing from the lot history records (lhr) as a test required for release of product, and 2) change lal endotoxin test procedure to instruct quality associates to collect product sample post-sterilization.