Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantCARL ZEISS MEDITEC AG
5160 Hacienda Drive
Dublin, CA 94568
PMA NumberP990048
Supplement NumberS003
Date Received04/22/2008
Decision Date10/31/2008
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LASER CONTROLLER; THE ADDITION OF NEW USER INTERFACE INCLUDING TOUCH-SENSITIEVE SCREEN AND ROTARY KNOBS; A NEW INTEGRATED POWER SUPPLY WITH MICRO-CONTROLLER ELECTRONIC COMPONENTS; NEW LABELING; AND NEW SOFTWARE (FIRMWARE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULAS 690PLUS AND VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE IN VISUDYNE THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE (VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS OR PATHOLOGIC MYOPIA.
-
-