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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 (SENOFILCON A) BRAND CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
7500 centurion parkway
suite 100 - erca
jacksonville, FL 32256
PMA NumberP040045
Supplement NumberS041
Date Received11/18/2013
Decision Date01/16/2014
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE IN THE VISCOSITY SPECIFICATION FROM 120-170 CPS TO100-170 CPS FOR THE REACTIVE MONOMER MIX.
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