OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
FDA premarket approval P940010/S003 · decided 1997-04-04
Approval details
- PMA number
- P940010
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1997-02-18
- Decision date
- 1997-04-04
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR LABELING CHANGES ASSOCIATED WITH THE INTRODUCTION OF A SECOND DISTRIBUTOR
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