PMA P910001S065
- Device
- CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S065
- Product code
- LPC
- Decision date
- 2014-01-14
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR NEW CIRCUITRY AND OPTICAL COMPONENTS TO IMPROVE CONTROL OF THE REGULATED ENERGY OUTPUT OF THE CVX-300 LASER GENERATOR.
Current openFDA PMA Record#
- Device
- CVX-300 EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S065
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2014-01-14
- Decision code
- APPR
- Date received
- 2013-04-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR NEW CIRCUITRY AND OPTICAL COMPONENTS TO IMPROVE CONTROL OF THE REGULATED ENERGY OUTPUT OF THE CVX-300 LASER GENERATOR.