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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.
 
DeviceSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPER VISION, INC.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS024
Date Received05/07/1997
Decision Date06/20/1997
Withdrawal Date 05/01/2014
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPOVAL FOR CONSOLIDATED AND REFORMATEED LABELING FOR THE ECLIPSE, SUNFLEX, TORIC 15.0, REVOLUTION, SPORTSOFT, APHAKIC, AND MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ECLIPSE(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, TORIC 15.0(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNFLEX(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, REVOLUTION (TM) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SPORTSOFT(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENS, AND SUNSOFT MULTIFOCAL(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES. THE INDICATIONS AND SHELF-LIFE FOR THESE DEVICES REMAIN UNCHANGED FROM THAT PREVIOUSLY APPROVED.
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