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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 U.S.A., INC.
PMA NumberP880098
Supplement NumberS010
Date Received06/30/1997
Decision Date08/25/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate packaging process where barnes hind(r) comfort care(r) gp wetting and soaking solution is added to the lens shipping case. Lenses will be shipped wet with a storage period of up to 30 days from the date of hydration.
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