PMA P990048S001

Device: VISULAS 690S AND VISULINK PDT/U ADAPTER
Applicant: Carl Zeiss Meditec, AG
PMA number: P990048
Supplement: S001
Product code: MVF
Decision date: 2001-09-27
Classification: System, Laser, Photodynamic Therapy
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR A REVISION OF THE INDICATION FOR USE STATEMENT TO READ "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 690S AND VISULINK PDT/U ADAPTER
Applicant: Carl Zeiss Meditec, AG
PMA number: P990048
Supplement: S001
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2001-09-27
Decision code: APPR
Date received: 2000-08-14
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A REVISION OF THE INDICATION FOR USE STATEMENT TO READ "FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS, OR PATHOLOGIC MYOPIA."