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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.
 
DeviceB&L(R) (AMEFOCON A) OXYGEN PERMEABLE LENS
Generic NameLens, contact (polymethylmethacrylate)
ApplicantBausch & Lomb, Inc.
14853 Deveau Pl.
Minnetonka, MN 55345
PMA NumberP830050
Supplement NumberS001
Date Received02/02/1987
Decision Date05/08/1987
Product Code HPX 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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