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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.
 
DeviceEXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP850079
Supplement NumberS039
Date Received12/06/2001
Decision Date01/17/2002
Product Codes LPM MVN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE FACILITY FOR PAD PRINTING LOCATED AT ASPECT VISION CARE, SOUTHAMPTON, UNITED KINGDOM.
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