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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 NameSOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUNILENS CORP., USA
PMA NumberP960039
Supplement NumberS001
Date Received06/25/1998
Decision Date07/09/1998
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing biological indicators.
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