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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.
 
DeviceGENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantCIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH, GA 30097
PMA NumberP890012
Supplement NumberS004
Date Received03/25/1999
Decision Date09/12/2000
Withdrawal Date 05/12/2009
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) A CHANGE IN MANUFACTURING METHOD FROM LATHE-CUT TO CAST-MOLDED; 2) A CHANGE IN HANDLING TINT FROM VAT DYES TO D & C GREEN #6; 3) TO ADD AN ULTRAVIOLET ABSORBER INTO NETRAFILCON A LENS MATERIAL; 4) AN ALTERNATE MANUFACTURING SITE AT WESLEY JESSEN PBH, LTD., SOUTHAMPTON, UNITED KINGDOM; 5) MODIFICATION TO THE INDICATINOS FOR USE INCLUDING THE SENTENCE "GENTLE TOUCH(TM) UV (NETRAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HELP TO PROTECT AGAINST THE TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE"; AND 6) MODIFICATION OF THE NOTE AND WARNING IN LABELING.
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