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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
6150 stoneridge mall road
suite 370
pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS024
Date Received05/07/1997
Decision Date06/20/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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.