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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.
 
DeviceETAFILCON HYDROPHILIC CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 CENTURION PKWY.
JACKSONVILLE, FL 32256
PMA NumberN18033
Supplement NumberS036
Date Received06/29/2001
Decision Date07/30/2001
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE PACKAGE INTEGRITY TEST METHOD TO SUPPORT SHELF-LIFE AND ASSIGN EXPIRATION DATES IN LIEU OF STERILITY TESTING.
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