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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 BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantOCULAR SCIENCES PUERTO RICO, INC.
PMA NumberP890023
Supplement NumberS008
Date Received07/29/1999
Decision Date08/13/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a uv blocker process change at ocular sciences' santa isabel facility.
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