PMA P910001S120
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S120
- Product code
- LPC
- Decision date
- 2023-08-31
- Classification
- Cardiovascular
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for the changes to the Philips Laser System device’s software to correct defects and the user interface
Current openFDA PMA Record#
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S120
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2023-08-31
- Decision code
- APPR
- Date received
- 2023-06-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the changes to the Philips Laser System device’s software to correct defects and the user interface