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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceHEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES
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 NumberS041
Date Received04/20/2009
Decision Date05/20/2009
Product Code
LPM
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to implement an alternate supplier for the critical material, hema, used in the production of the device.
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