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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFREQUENCY 55 UV (SPHERICAL & TORIC ) SOFT CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPERVISION, INC.
370 woodcliff drive
suite 200
fairport, NY 14450-0000
PMA NumberP850079
Supplement NumberS031
Date Received04/14/1999
Decision Date07/28/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Frequency(TM) 55 UV lens in spherical and toric configuration for extended wear.
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