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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 NameMETHAFILCON A
Classification Namelenses, soft contact, extended wear
Generic Namesoft hydrophilic contact lenses
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP850079
Supplement NumberS030
Date Received03/11/1999
Decision Date04/15/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate tinting process, in-monomer-tinting process.
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