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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode LPB PMA Number p Decision Date From 1/1/2008 Decision Date To 1/1/2009
 
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NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTI... BIOSENSE WEBSTER, INC. P030031 S013 12/24/2008
THERAPY CARDIAC ABLATION CATHETER IRVINE BIOMEDICAL, INC. P040014 S009 12/10/2008
FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTR... Medtronic CryoCath LP P020045 S025 11/14/2008
NAVISTAR RMT CATHETER FAMILY BIOSENSE WEBSTER, INC. P030031 S012 11/07/2008
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERA... BIOSENSE WEBSTER, INC. P040036 S009 11/07/2008
NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CAT... BIOSENSE WEBSTER, INC. P990025 S016 11/07/2008
HELIOS II ABLATION CATHETER STEREOTAXIS, INC. P050029 10/10/2008
STEEROCATH T CARDIAC ABLATION CATHETER Boston Scientific Corp. P920047 S038 10/10/2008
EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DI... BIOSENSE WEBSTER, INC. P030031 S009 09/30/2008
EZ STEER THERMOCOOL AND BIOSENSE WEBSTER, INC. P040036 S006 09/30/2008
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