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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 63 Results
productcode LPB PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
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Device
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PMA
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NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ S... Biosense Webster, Inc P950005 S046 10/09/2013
EPT-1000 CARDIAC ABLATION SYSTEM Boston Scientific Corp. P920047 S060 10/07/2013
CHILLI COOLED ABLATION SYSTEM Boston Scientific Corp. P980003 S041 10/07/2013
FREEZOR CARDIAC ABLATION CATHETER Medtronic CryoCath LP P020045 S050 09/27/2013
THERAPY ABLATION CATHETERS IRVINE BIOMEDICAL, INC. P040014 S020 09/27/2013
BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERA... Boston Scientific Corp. P920047 S059 09/27/2013
CHILLI II COOLED ABLATION CATHETER Boston Scientific Corp. P980003 S040 09/27/2013
CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL... BIOSENSE WEBSTER, INC. P030031 S055 09/05/2013
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCO... BIOSENSE WEBSTER, INC. P040036 S039 09/05/2013
CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CAT... Biosense Webster, Inc P950005 S045 09/05/2013
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