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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) CONDITIONING SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantPolymer Technology Corp.
1400 N Goodman St.
Rochester, NY 14692
PMA NumberP820070
Supplement NumberS015
Date Received10/17/1989
Decision Date07/13/1990
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day 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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