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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 BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS
Generic NameLenses, soft contact, extended wear
ApplicantVistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS034
Date Received11/03/2000
Decision Date05/18/2001
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING THE MANUFACTURING FACILITY AT VISTAKON, JOHNSON & JOHNSON (IRELAND) LTE., LIMERICK, IRELAND, FOR THE MANUFACTURE OF ACCUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENSES.
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