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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 NumberS012
Date Received10/26/1987
Decision Date12/01/1987
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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