OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
FDA premarket approval P940010/S014 · decided 2018-01-30
Approval details
- PMA number
- P940010
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2018-01-16
- Decision date
- 2018-01-30
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Replace the current final diffuser tip axial load test method with a test method that is currently performed as an in-process diffuser tip axial load test and to eliminate the requirement for an in-process diffuser tip axial load test.
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