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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 EQUALENS(R) AND BOSTON RXD(R)
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 N. GOODMAN ST.
ROCHESTER, NY 14692
PMA NumberP860022
Supplement NumberS047
Date Received05/01/1995
Decision Date06/05/1995
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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