OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)
FDA premarket approval P940010/S016 · decided 2019-05-09
Approval details
- PMA number
- P940010
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2018-12-19
- Decision date
- 2019-05-09
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for the design update for the OPTIGUIDE Diffusing Fiber Optics for the new series identified as the PB200 and PB700 Series of OPTIGUIDE Diffusing Fiber Optics and for the approval of a new manufacturing site. The new manufacturing site is Laser Peripherals LLC, 13355 10th Avenue, North Suite #110, Plymouth, Minnesota.
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