ANGIO DYNAMICS 630PDT LASER
FDA premarket approval P990021/S002 · decided 2010-10-13
Approval details
- PMA number
- P990021
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO DYNAMICS 630PDT LASER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2009-05-26
- Decision date
- 2010-10-13
- Days to decision
- 505 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR THE USE OF AN ALTERNATIVE SOURCE OF LASER DIODE AND MODIFICATION OF THE THERMAL MANAGEMENT OF THE DEVICE.
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