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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 (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS040
Date Received09/05/2006
Decision Date10/31/2006
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING POLYVINYLPYRROLI-DONE (PROVIDONE) TO THE PACKING SOLUTION FOR THE DEVICE.
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