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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 SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namesoft hydrophilic contact lenses
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP850079
Supplement NumberS041
Date Received08/20/2002
Decision Date02/12/2003
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility located at coopervision, inc. , norfolk, virginia.
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