FDA.reportPublic FDA data

PMA P940010

Device
OPTIGUIDE Cylindrical Fiber Optic
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S017
Product code
MVG
Decision date
2021-02-24
Generic name
System, laser, fiber optic, photodynamic therapy
Approval order statement
Approval for the addition of the PB900 series to OPTIGUIDE® Cylindrical Diffuser fiber optics. The change being made (due to addition of the fiber that is equivalent to PB200 and PB700 fibers) is in two quality control procedures to accommodate the smaller diameter of this design.

Current openFDA PMA Record#

Device
OPTIGUIDE Cylindrical Fiber Optic
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S017
Product code
MVG
Generic name
System, laser, fiber optic, photodynamic therapy
Decision date
2021-02-24
Decision code
APPR
Date received
2020-11-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of the PB900 series to OPTIGUIDE® Cylindrical Diffuser fiber optics. The change being made (due to addition of the fiber that is equivalent to PB200 and PB700 fibers) is in two quality control procedures to accommodate the smaller diameter of this design.