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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.
 
DeviceMETHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
370 Woodcliff Dr.
Suite 200
Fairport, NY 14450
PMA NumberP850079
Supplement NumberS072
Date Received01/19/2017
Decision Date02/13/2017
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  
Use of Getinge autoclave A as back up equipment for the sterilization of lathing produced products (3 pack Blisters and Vials) in the event of breakdown or service of lathing autoclaves K and M at the CooperVision, Inc. Hamble UK manufacturing facility.
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