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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.
 
DeviceTHE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS
Generic NameLens, contact (polymethylmethacrylate)
ApplicantUnilens Corp., USA
10431 72nd St. N.
P.O. Box 2530
Largo, FL 34647
PMA NumberP850008
Supplement NumberS001
Date Received08/14/1986
Decision Date12/01/1986
Product Code HPX 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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