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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.
 
DevicePERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
6150 STONERIDGE MALL ROAD
SUITE 500
PLEASANTON, CA 94588
PMA NumberP780010
Supplement NumberS022
Date Received04/18/2001
Decision Date11/16/2001
Withdrawal Date 06/11/2014
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN INITIATOR FOR THE REFERENCED DEVICES MANUFACTURED AT AN ALTERNATE MANUFACTURING SITE LOCATED IN COOPERVISION, HUNTINGTON BEACH, CALIFORNIA.
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