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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser
ApplicantCARL ZEISS MEDITEC AG
PMA NumberP990048
Date Received08/16/1999
Decision Date04/12/2000
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 00M-1300
Notice Date 04/12/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
Approval Order Approval Order
Supplements: S001 S002 S003 
-
-