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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.
 
DeviceBIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantCooperVision, Inc.
370 Woodcliff Dr.
Suite 200
Fairport, NY 14450
PMA NumberP780007
Supplement NumberS042
Date Received09/17/1999
Decision Date12/14/1999
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new manufacturing facility located at Ocular Sciences/American Hydron, Juana Diaz Industrial Park, 500 Road 531, Juana Diaz, Puerto Rico.
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