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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.
 
DeviceFINISHED METHAFILCON A CONTACT LENSES
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantLombart Lenses, Ltd.
1215 Boissevain Ave.
Norfolk, VA 23507
PMA NumberP890049
Supplement NumberS001
Date Received09/14/1989
Decision Date10/10/1989
Withdrawal Date11/13/2007
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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