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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 10 Results
productcode MRA PMA Number p Decision Date From 1/1/2007 Decision Date To 1/1/2008
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Device
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PMA
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C2-A TAPER ACETABULAR SYSTEM Biomet, Inc. P050009 S005 11/30/2007
DURALOC OPTION CERAMIC HIP SYSTEM DEPUY ORTHOPAEDICS, INC. P040023 S010 11/14/2007
REFLECTION CERAMIC ACETABULAR HIP SYSTEM Smith & Nephew, Inc. P030022 S006 10/12/2007
DURALOC OPTION CERAMIC HIP SYSTEM DEPUY ORTHOPAEDICS, INC. P040023 S009 09/03/2007
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM CERAMTEC GMBH P010001 S004 08/17/2007
REFLECTION CERAMIC ACETABULAR SYSTEM Smith & Nephew, Inc. P030022 S003 08/14/2007
NOVATION CERAMIC ARTICULATION HIP SYSTEM EXACTECH, INC. P050039 07/05/2007
TRILOGY AB ACETABULAR SYSTEM ZIMMER, INC. P040048 S002 06/08/2007
REFLECTION CERAMIC HIP SYSTEM Smith & Nephew, Inc. P030022 S004 05/04/2007
OSTEONICS ABC / TRIDENT SYSTEMS HOWMEDICA OSTEONICS CORP. P000013 S008 04/26/2007
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