• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
11460 johns creek parkway
duluth, GA 30097
PMA NumberP890012
Supplement NumberS004
Date Received03/25/1999
Decision Date09/12/2000
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) a change in manufacturing method from lathe-cut to cast-molded; 2) a change in handling tint from vat dyes to d & c green #6; 3) to add an ultraviolet absorber into netrafilcon a lens material; 4) an alternate manufacturing site at wesley jessen pbh, ltd. , southampton, united kingdom; 5) modification to the indicatinos for use including the sentence "gentle touch(tm) uv (netrafilcon a) soft (hydrophilic) contact lenses help to protect against the transmission of harmful uv radiation to the cornea and into the eye"; and 6) modification of the note and warning in labeling.