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 Excimer Laser System and ELCA Coronary Atherectomy Catheters
• Generic Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Applicant: Spectranetics Corp.; 9965 Federal Dr.; Colorado Springs, CO 80921
• PMA Number: P910001
• Supplement Number: S107
• Date Received: 09/24/2018
• Decision Date: 10/15/2018
• 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  
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