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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMENICON SF-P (MELAFOCON A) CONTACT LENS
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantMENICON CO. LTD.
PMA NumberP880098
Supplement NumberS009
Date Received01/04/1996
Decision Date04/03/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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