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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 NameCOOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namesoft hydrophilic contact lenses
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
PMA NumberP850079
Supplement NumberS063
Date Received12/12/2012
Decision Date02/21/2014
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacture of the device on another manufacturing line and further that orders with low volume requirements will be lathed on the front surface, rather than fully molded as large volume orders are.
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