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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 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
Generic NameLenses, soft contact, extended wear
ApplicantVistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS039
Date Received12/22/2003
Decision Date02/04/2004
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 FOR AN ALTERNATIVE BINDING POLYMER TO THE ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER.
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