PMA P940010S008
- Device
- OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S008
- Product code
- MVG
- Decision date
- 2000-07-07
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order 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.
Current openFDA PMA Record#
- Device
- OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S008
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2000-07-07
- Decision code
- APPR
- Date received
- 1999-09-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.