PMA P910001S123
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S123
- Product code
- LPC
- Decision date
- 2024-11-21
- Classification
- Cardiovascular
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- approval for a change to the adhesive used in the internal energy sensors of the Philips Laser System
Current openFDA PMA Record#
- Device
- Philips Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S123
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2024-11-21
- Decision code
- APPR
- Date received
- 2024-09-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a change to the adhesive used in the internal energy sensors of the Philips Laser System