PMA P990048S002

Device: VISULAS 690S LASER AND VISULINK PDT ADAPTER
Applicant: Carl Zeiss Meditec, AG
PMA number: P990048
Supplement: S002
Product code: MVF
Decision date: 2001-07-03
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE VISULINK PDT ADAPTER IN ORDER TO MAKE THE VISULAS 790S LASER COMPATIBLE WITH BOTH ZEISS AND HAAG STREIT SLIT LAMPS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE WITH THE VISULAS 690S LASER THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE(VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION (AMD) IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION( CNV).

Current openFDA PMA Record#

Device: VISULAS 690S LASER AND VISULINK PDT ADAPTER
Applicant: Carl Zeiss Meditec, AG
PMA number: P990048
Supplement: S002
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2001-07-03
Decision code: APPR
Date received: 2001-03-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE VISULINK PDT ADAPTER IN ORDER TO MAKE THE VISULAS 790S LASER COMPATIBLE WITH BOTH ZEISS AND HAAG STREIT SLIT LAMPS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE WITH THE VISULAS 690S LASER THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE(VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION (AMD) IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION( CNV).