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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.
 
Trade NameHYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
Classification Namelenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCOOPERVISION, INC.
PMA NumberP850079
Supplement NumberS028
Date Received07/12/1996
Decision Date08/01/1996
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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