Optiguide Fiber Optic Diffuser
FDA premarket approval P940010/S015 · decided 2018-05-18
Approval details
- PMA number
- P940010
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optiguide Fiber Optic Diffuser
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2018-04-03
- Decision date
- 2018-05-18
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval of shelf life for the OPTIGUIDE Fiber Optic Diffuser, DCYL 700 Cylindrical Diffuser Series for four (4) years in all sizes of the DCYL 700 Series fibers (DCYL 710, 715, 720, 725, 750).
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