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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.
 
Deviceocufilcon D Sift (Hydrophilie) Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantThe Cooper Companies
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS028
Date Received08/04/2017
Decision Date12/19/2017
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in the test specifications of the saline solutions that are manufactured at the CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico and used in the packaging of ocufilcon D Soft (Hydrophilic) Contact Lenses in blister containers.
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