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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.
 
DeviceBOSTON LENS(R) LENS - CLEAR
Generic NameLens, contact (polymethylmethacrylate)
ApplicantPolymer Technology Corp.
100 Research Dr.
Wilmington, MA 01887
PMA NumberP820065
Supplement NumberS055
Date Received05/13/1988
Decision Date07/21/1988
Product Code HPX 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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