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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.
 
Device ISTAMARC TORIC (ETAFILCONA))
Classification Namelenses, soft contact, daily wear
Generic Namelenses, soft contact, daily wear
Regulation Number886.5925
Applicant
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 centurion pkwy.
jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS017
Date Received09/16/1987
Decision Date10/05/1987
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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