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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.
 
Trade NameGENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namegentle touch uv
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP890012
Supplement NumberS005
Date Received02/28/2000
Decision Date05/02/2000
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site transfer to wesley jessen inc. , cidra, puerto rico.
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