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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYDROGENICS 60 (OCUFILCON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantTHE COOPER COMPANIES
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS014
Date Received12/22/2003
Decision Date01/14/2004
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING SITES LOCATED AT OCULAR SCIENCES PUERTO RICO IN JUANA DIAZ, PUERTO RICO AND SANTA ISABEL, PUERTO RICO.
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