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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.
 
DeviceSATURN II(TM) (SYNERGICON A) CONTACT LENS
Generic NameLens, contact (polymethylmethacrylate)
ApplicantWesley Jessen Corp.
333 E. Howard Ave.
Des Plaines, IL 60018
PMA NumberP840004
Supplement NumberS003
Date Received11/25/1986
Decision Date01/29/1987
Product Code HPX 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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