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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.
 
DeviceCUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH, GA 30097
PMA NumberP850057
Supplement NumberS006
Date Received12/23/1999
Decision Date09/18/2000
Withdrawal Date 06/10/2009
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.
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