PMA P990048S003

Device: VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER
Applicant: Carl Zeiss Meditec, AG
PMA number: P990048
Supplement: S003
Product code: MVF
Decision date: 2008-10-31
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR CHANGES TO THE LASER CONTROLLER; THE ADDITION OF NEW USER INTERFACE INCLUDING TOUCH-SENSITIEVE SCREEN AND ROTARY KNOBS; A NEW INTEGRATED POWER SUPPLY WITH MICRO-CONTROLLER ELECTRONIC COMPONENTS; NEW LABELING; AND NEW SOFTWARE (FIRMWARE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULAS 690PLUS AND VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE IN VISUDYNE THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE (VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS OR PATHOLOGIC MYOPIA.

Current openFDA PMA Record#

Device: VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER
Applicant: Carl Zeiss Meditec, AG
PMA number: P990048
Supplement: S003
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2008-10-31
Decision code: APPR
Date received: 2008-04-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE LASER CONTROLLER; THE ADDITION OF NEW USER INTERFACE INCLUDING TOUCH-SENSITIEVE SCREEN AND ROTARY KNOBS; A NEW INTEGRATED POWER SUPPLY WITH MICRO-CONTROLLER ELECTRONIC COMPONENTS; NEW LABELING; AND NEW SOFTWARE (FIRMWARE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULAS 690PLUS AND VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE IN VISUDYNE THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE (VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS OR PATHOLOGIC MYOPIA.