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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.
 
DeviceHYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP850079
Supplement NumberS028
Date Received07/12/1996
Decision Date08/01/1996
Product Code LPL 
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  
APPROVAL FOR REFORMATTING THE PACKAGE INSERT, PROFESSIONAL FITTING AND INFORMATION GUIDE, AND PATIENT INSTRUCTIONS. THE MODIFIED LABELING DOES NOT RESULT IN CHANGES IN THE INDICATIONS FOR USE FOR THE DEVICES
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