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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.
 
DeviceMENICON SF-P (MELAFOCON A) CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantMenicon Co, Ltd.
269 A Ballardvale St.
Wilmington, MA 01887
PMA NumberP880098
Supplement NumberS009
Date Received01/04/1996
Decision Date04/03/1996
Withdrawal Date05/05/2008
Product Code LPM 
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
Approval Order Statement  
APPROVAL FOR LABELING CHANGES INCLUDING ADDING TO THE APPROVED LABELING ALLERGAN INC.'S DESTAT 4 SYSTEM AND ALCON LABORATORIES, INC.'S OPTI-SOAK SYSTEM. NO FURHTER CHANGES WILL BE MADE IN THE LABELING.
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