PMA P910001S097
- Device
- CVX-300-P Excimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S097
- Product code
- LPC
- Decision date
- 2018-06-29
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for a design change to the Thyratron driver printed circuit assembly.
Current openFDA PMA Record#
- Device
- CVX-300-P Excimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S097
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2018-06-29
- Decision code
- APPR
- Date received
- 2017-08-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the Thyratron driver printed circuit assembly.