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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 TORIC & SPHERE (METHAFILCON A 55%) SOFT (HYDROPHILIC) CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
370 Woodcliff Dr.
Suite 200
Fairport, NY 14450
PMA NumberP850079
Supplement NumberS046
Date Received10/13/2009
Decision Date01/29/2010
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MIGRATION FROM A MANUAL TO AN AUTOMATIC WET LENS INSPECTION SYSTEM.
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