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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 NameFREQUENCY TORIC & SPHERE (METHAFILCON A 55%) SOFT (HYDROPHILIC) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namesoft hydrophilic contact lenses
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
PMA NumberP850079
Supplement NumberS046
Date Received10/13/2009
Decision Date01/29/2010
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 migration from a manual to an automatic wet lens inspection system.
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