Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: CVX-300 and CVX-300-P Excimer Laser Systems
• Generic Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Applicant: Spectranetics Corp.; 9965 Federal Dr.; Colorado Springs, CO 80921
• PMA Number: P910001
• Supplement Number: S106
• Date Received: 08/30/2018
• Decision Date: 09/25/2018
• Product Code: LPC
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Use of a new receiving inspection tool, FARO Articulating Arm Coordinated Measurement Machine, to measure flatness during component production.