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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.
 
Device(MAFILCON) SOFT CONTACT LENSES
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantN&N Menicon, Inc.
4201 198th SW #1035
Lynnwood, WA 98036
PMA NumberP800031
Supplement NumberS001
Date Received11/04/1988
Decision Date05/05/1989
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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