PMA P990021S002
- Device
- ANGIO DYNAMICS 630PDT LASER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S002
- Product code
- MVF
- Decision date
- 2010-10-13
- Classification
- System, Laser, Photodynamic Therapy
- Generic name
- System, laser, photodynamic therapy
- Approval order statement
- APPROVAL FOR THE USE OF AN ALTERNATIVE SOURCE OF LASER DIODE AND MODIFICATION OF THE THERMAL MANAGEMENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ANGIO DYNAMICS 630PDT LASER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S002
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2010-10-13
- Decision code
- APPR
- Date received
- 2009-05-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF AN ALTERNATIVE SOURCE OF LASER DIODE AND MODIFICATION OF THE THERMAL MANAGEMENT OF THE DEVICE.