PMA P910001S089
- Device
- CVX-300 and CVX-300-P EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S089
- Product code
- LPC
- Decision date
- 2018-07-27
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval to modify the coating applied to the optics of the laser and minor design changes to accommodate the change in coating.
Current openFDA PMA Record#
- Device
- CVX-300 and CVX-300-P EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S089
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2018-07-27
- Decision code
- APPR
- Date received
- 2016-11-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the coating applied to the optics of the laser and minor design changes to accommodate the change in coating.