|
Device | COHERENT OPAL PHOTOACTIVATOR |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | LUMENIS 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 |
PMA Number | P990049 |
Supplement Number | S001 |
Date Received | 08/16/2000 |
Decision Date | 09/27/2001 |
Withdrawal Date
|
09/10/2010 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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." |