PMA P910001S115
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S115
- Product code
- LPC
- Decision date
- 2022-05-05
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for a new design specification and inspection requirement to be implemented during manufacturing of the Philips Laser System.
Current openFDA PMA Record#
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S115
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2022-05-05
- Decision code
- APPR
- Date received
- 2022-02-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new design specification and inspection requirement to be implemented during manufacturing of the Philips Laser System.