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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 NamePERMAFLEX NATURALS
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP790020
Supplement NumberS059
Date Received10/13/1998
Decision Date10/27/1998
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a ten year expiration date for the permaflex naturals (surfilcon a) hydrophilic contact lenses.
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