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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.
 
DevicePOLYMACON CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP780007
Supplement NumberS041
Date Received02/06/1996
Decision Date09/27/1996
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE REFERENCED DEVICE AT RELIANT CLOSE, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND
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