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Device | VISULAS 690S LASER AND VISULINK PDT ADAPTER |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | CARL ZEISS MEDITEC AG 5160 Hacienda Drive Dublin, CA 94568 |
PMA Number | P990048 |
Supplement Number | S002 |
Date Received | 03/09/2001 |
Decision Date | 07/03/2001 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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). |