Optiguide Cylindrical Fiber Optic
FDA premarket approval P940010/S013 · decided 2018-01-13
Approval details
- PMA number
- P940010
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optiguide Cylindrical Fiber Optic
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2017-12-18
- Decision date
- 2018-01-13
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Addition of a manual heating method to be added as an alternative method for the formation of the rounded tip of the cap sub-assembly using ETFE tubing.
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