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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) CONTACT LENS FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
ApplicantCooperVision, Inc.
370 Woodcliff Dr.
Suite 200
Fairport, NY 14450
PMA NumberP850079
Supplement NumberS041
Date Received08/20/2002
Decision Date02/12/2003
Product Codes LPM MVN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT COOPERVISION, INC., NORFOLK, VIRGINIA.
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