OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series)
FDA premarket approval P940010/S012 · decided 2018-01-17
Approval details
- PMA number
- P940010
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series)
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2017-10-24
- Decision date
- 2018-01-17
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for replacement resin for the manufacturing of "heat shrink" tubing used in all sizes of the DCYL 200 Series fibers (DCYL 210, 215,220,225, 250).
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