• 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.
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
3959 west 1820 south
salt lake city, UT 84104
PMA NumberP990049
Date Received08/20/1999
Decision Date04/12/2000
Withdrawal Date 09/10/2010
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 00M-1299
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