PMA P910001S111
- Device
- Spectranetics CVX-300 Excimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S111
- Product code
- LPC
- Decision date
- 2020-12-22
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for minor design changes to the Fiber Coupler Assembly.
Current openFDA PMA Record#
- Device
- Spectranetics CVX-300 Excimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S111
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2020-12-22
- Decision code
- APPR
- Date received
- 2020-10-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the Fiber Coupler Assembly.