OPTIGUIDE Cylindrical Fiber Optic
FDA premarket approval P940010/S017 · decided 2021-02-24
Approval details
- PMA number
- P940010
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIGUIDE Cylindrical Fiber Optic
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2020-11-02
- Decision date
- 2021-02-24
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for the addition of the PB900 series to OPTIGUIDE® Cylindrical Diffuser fiber optics. The change being made (due to addition of the fiber that is equivalent to PB200 and PB700 fibers) is in two quality control procedures to accommodate the smaller diameter of this design.
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