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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.
 
DeviceFOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP820021
Supplement NumberS028
Date Received06/27/1995
Decision Date03/18/1996
Withdrawal Date 08/28/2019
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN AUTOMATED MANUFACTURING LINE AND PROCESS FOR FOCUS AND NEWVUES (VIFILCON A) SOFT (HYDROPHILIC( CONTACT LENSES
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