PMA P910001S121
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S121
- Product code
- LPC
- Decision date
- 2023-10-30
- Classification
- Cardiovascular
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- approval for a second semiconductor supplier for laser assembly internal hardware
Current openFDA PMA Record#
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S121
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2023-10-30
- Decision code
- APPR
- Date received
- 2023-08-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a second semiconductor supplier for laser assembly internal hardware