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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 38 Results
productcode LPB PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
 
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FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA... Medtronic CryoCath LP P020045 S041 01/13/2012
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S033 01/13/2012
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S024 01/13/2012
CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE... Biosense Webster, Inc P950005 S033 02/08/2012
CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PU... Boston Scientific Corp. P980003 S034 02/15/2012
BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETER... Boston Scientific Corp. P920047 S048 03/23/2012
ATAKR RFCA SYSTEM MEDTRONIC Inc. P930029 S036 03/23/2012
CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES Boston Scientific Corp. P980003 S030 03/23/2012
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P030031 S040 03/30/2012
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P040036 S029 03/30/2012
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