PMA P910001S106

Device: CVX-300 and CVX-300-P Excimer Laser Systems
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S106
Product code: LPC
Decision date: 2018-09-25
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: Use of a new receiving inspection tool, FARO Articulating Arm Coordinated Measurement Machine, to measure flatness during component production.

Current openFDA PMA Record#

Device: CVX-300 and CVX-300-P Excimer Laser Systems
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S106
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2018-09-25
Decision code: OK30
Date received: 2018-08-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Use of a new receiving inspection tool, FARO Articulating Arm Coordinated Measurement Machine, to measure flatness during component production.