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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
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPERVISION, INC.
370 woodcliff drive
suite 200
fairport, NY 14450-0000
PMA NumberP850079
Supplement NumberS039
Date Received12/06/2001
Decision Date01/17/2002
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATE FACILITY FOR PAD PRINTING LOCATED AT ASPECT VISION CARE, SOUTHAMPTON, UNITED KINGDOM.
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