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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.
 
DeviceACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
Generic NameLenses, soft contact, extended wear
ApplicantVistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS030
Date Received05/02/1997
Decision Date05/14/1997
Product Codes LPM LPL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MAKE A MINOR CHANGE IN THE INITIATOR RATIO (INCREASED AMOUNT) FOR THE ACUVUE(R) (ETAFILCON A) CONTACT LENS, WHICH WAS APPROVED AS N18-033/S29 ON OCTOBER 7, 1996. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE CURRENT TRADE NAME WITH NO CHANGE TO THE INDICATIONS FOR USE OR THE ESTABLISHED SHELF-LIFE.
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