PMA P990049

Device: COHERENT OPAL PHOTOACTIVATOR
Applicant: Lumenis
PMA number: P990049
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 AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA OR PRESUMED OCULAR HISTOPLASMOSIS."

Current openFDA PMA Record#

Device: COHERENT OPAL PHOTOACTIVATOR
Applicant: Lumenis
PMA number: P990049
Supplement: S001
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2001-09-27
Decision code: APPR
Date received: 2000-08-16
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 AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA OR PRESUMED OCULAR HISTOPLASMOSIS."