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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 NameHYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberN17752
Supplement NumberS038
Date Received03/30/2001
Decision Date08/16/2001
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility located at ciba vision (formerly wesley jessen), cidra, puerto rico.
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