|Trade Name||SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM|
|Classification Name||device, angioplasty, laser, coronary|
|Generic Name||coronary angioplasty catheter|
|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.