FDA.reportPublic FDA data

PMA P940010S016

Device
OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S016
Product code
MVG
Decision date
2019-05-09
Classification
System, Laser, Fiber Optic, Photodynamic Therapy
Generic name
System, laser, fiber optic, photodynamic therapy
Approval order statement
Approval for the design update for the OPTIGUIDE Diffusing Fiber Optics for the new series identified as the PB200 and PB700 Series of OPTIGUIDE Diffusing Fiber Optics and for the approval of a new manufacturing site. The new manufacturing site is Laser Peripherals LLC, 13355 10th Avenue, North Suite #110, Plymouth, Minnesota.

Current openFDA PMA Record#

Device
OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S016
Product code
MVG
Generic name
System, laser, fiber optic, photodynamic therapy
Decision date
2019-05-09
Decision code
APPR
Date received
2018-12-19
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the design update for the OPTIGUIDE Diffusing Fiber Optics for the new series identified as the PB200 and PB700 Series of OPTIGUIDE Diffusing Fiber Optics and for the approval of a new manufacturing site. The new manufacturing site is Laser Peripherals LLC, 13355 10th Avenue, North Suite #110, Plymouth, Minnesota.