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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.
 
DeviceBiomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses Extended Wear
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantThe Cooper Companies
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS045
Date Received08/24/2020
Decision Date09/22/2020
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Qualification of a wet line for the manufacture of Biomedics 55 Asphere (ocufilcon D) extended wear contact lenses with a base curve of 8.6 mm at the CooperVision facility located in Scottsville, New York.
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