PMA P940010S001

Device: OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
Applicant: Pinnacle Biologics, Inc.
PMA number: P940010
Supplement: S001
Product code: MVG
Decision date: 1996-08-07
Classification: System, Laser, Fiber Optic, Photodynamic Therapy
Generic name: System, laser, fiber optic, photodynamic therapy
Approval order statement: APPROVAL FOR CHANGE IN LABELING CONSISTING OF ADDING AN ADDITIONAL WARNING STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP

Current openFDA PMA Record#

Device: OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
Applicant: Pinnacle Biologics, Inc.
PMA number: P940010
Supplement: S001
Product code: MVG
Generic name: System, laser, fiber optic, photodynamic therapy
Decision date: 1996-08-07
Decision code: APPR
Date received: 1996-07-03
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGE IN LABELING CONSISTING OF ADDING AN ADDITIONAL WARNING STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP