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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.
 
DeviceOTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantOcular Technologies, Inc.
3803b Computer Dr.
Raleigh, NC 27609
PMA NumberP890031
Supplement NumberS003
Date Received03/14/1990
Decision Date04/25/1991
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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