OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC
FDA premarket approval P940010/S008 · decided 2000-07-07
Approval details
- PMA number
- P940010
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1999-09-21
- Decision date
- 2000-07-07
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR THE ADDITION OF SURGICAL TECHNOLOGIES, INC. AS AN ALTERNATE PACKAGING AND STERILIZATION SITE, AND MODIFICATIONS TO THE FIBER OPTIC REEL AND PRIMARY PACKAGING BOX.
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