OPTIGUIDE CYLINDRICAL FIBER OPTIC
FDA premarket approval P940010/S007 · decided 1999-08-13
Approval details
- PMA number
- P940010
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTIGUIDE CYLINDRICAL FIBER OPTIC
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1999-07-08
- Decision date
- 1999-08-13
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols.
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