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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NameBIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantOCULAR SCIENCES PUERTO RICO, INC.
PMA NumberP890023
Supplement NumberS007
Date Received04/20/1999
Decision Date05/10/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a ultraviolet blocker into the matrix of the biomedics 55 (ocufilcon d) soft (hydrophilic) lens for extended wear, a change in the indications statement to add the sentence "biomedics uv blocking contact lenses help protect against transmission of harmful uv radiation ot the cornea and in the eye;" and a modified warning and note.
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