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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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PMA
Number
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Decision
Date
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disinfecting unit iii Bausch & Lomb, Inc. N16895S015 12/04/1981
osteo ceramic hip Smith & Nephew, Inc. P810048S007 03/22/1985
b&l therma-zyme, fizziclean Bausch & Lomb, Inc. P850093S002 09/02/1988
scimed ptca dilatation catheter SCIMED LIFE SYSTEMS, INC. P860019S016 02/21/1989
fluorex (tm) 600 (flursilfocon a) G.T. LABORATORIES, INC. P880001S012 04/18/1989
one piece posterior chamber lenses BAUSCH & LOMB P790027S055 06/15/1990
novacol(tm) textured collagen hemostatic agent Datascope Corp. P850023S009 09/28/1990
microscan rapid fluorogenic panels DADE INTL., INC. P870049S009 01/08/1991
edap lt.01 shock wave lithotripter EDAP INTERNATIONAL CORP. P880042 12/12/1991
therasonic lithotripsy treatment system FOCUS SURGERY, INC. P890066S001 03/01/1992

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