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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 NameBIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION MANUFACTURING, LTD.
PMA NumberP080011
Supplement NumberS029
Date Received02/03/2014
Decision Date06/03/2014
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new brand names biofinity xr toric and biofinity xr multifocal.
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