• 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 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.
 
DeviceZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
CARL ZEISS MEDITEC AG
5160 hacienda drive
dublin, CA 94568
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
Approval Order Statement 
Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Supplements: S001 S002 S003 
-
-