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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 Xcel Toric (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses. / Frequency Xcel Toric XR (methaf
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
370 Woodcliff Dr.
Suite 200
Fairport, NY 14450
PMA NumberP850079
Supplement NumberS076
Date Received10/26/2017
Decision Date11/22/2017
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Introduction of a new Rapid Readout Biological Indicators (RRBIs) incubator and the reduction in the number of RRBIs.
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