PMA P910001S078
- Device
- CVX-300/CVX300-P EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S078
- Product code
- LPC
- Decision date
- 2015-10-20
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE ANTI-REFLECTIVE COATING THAT IS APPLIED TO THE LASER VESSEL WINDOWS.
Current openFDA PMA Record#
- Device
- CVX-300/CVX300-P EXCIMER LASER SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S078
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2015-10-20
- Decision code
- APPR
- Date received
- 2015-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE ANTI-REFLECTIVE COATING THAT IS APPLIED TO THE LASER VESSEL WINDOWS.