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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.
 
DevicePERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
SANTA ANA, CA 92705
PMA NumberP790020
Supplement NumberS057
Date Received09/25/1996
Decision Date11/21/1996
Withdrawal Date 07/19/2006
Product Code LPM 
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  
CHANGES TO THE LABELING TO COMBINE THE PROFESSIONAL FITTING GUIDE, INSTRUCTIONS FOR WEARER BOOKLET, AND PACKAGE INSERT
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