PMA P940010S013
- Device
- Optiguide Cylindrical Fiber Optic
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S013
- Product code
- MVG
- Decision date
- 2018-01-13
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- Addition of a manual heating method to be added as an alternative method for the formation of the rounded tip of the cap sub-assembly using ETFE tubing.
Current openFDA PMA Record#
- Device
- Optiguide Cylindrical Fiber Optic
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S013
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2018-01-13
- Decision code
- OK30
- Date received
- 2017-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a manual heating method to be added as an alternative method for the formation of the rounded tip of the cap sub-assembly using ETFE tubing.