PMA P940010S012

Device
OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series)
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S012
Product code
MVG
Decision date
2018-01-17
Classification
System, Laser, Fiber Optic, Photodynamic Therapy
Generic name
System, laser, fiber optic, photodynamic therapy
Approval order statement
Approval for replacement resin for the manufacturing of "heat shrink" tubing used in all sizes of the DCYL 200 Series fibers (DCYL 210, 215,220,225, 250).
Summary
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Current openFDA PMA Record#

Device
OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series)
Applicant
Pinnacle Biologics, Inc.
PMA number
P940010
Supplement
S012
Product code
MVG
Generic name
System, laser, fiber optic, photodynamic therapy
Decision date
2018-01-17
Decision code
APPR
Date received
2017-10-24
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for replacement resin for the manufacturing of "heat shrink" tubing used in all sizes of the DCYL 200 Series fibers (DCYL 210, 215,220,225, 250).