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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.
 
DeviceVISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 centurion pkwy.
jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS028
Date Received02/06/1996
Decision Date03/05/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR UTILIZING AN ALTERNATE PROTOCOL FOR ESTABLISHING SHELF-LIFE STABILITY
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