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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 85 Results
productcode LPB PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
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Device
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PMA
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CHILLI II COOLED ABLATION CATHETER AND CABLE Boston Scientific Corp. P980003 S064 10/13/2015
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERA... Boston Scientific Corp. P920047 S085 10/01/2015
CRYOABLATION SYSTEM Medtronic CryoCath LP P020045 S067 09/28/2015
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR BIOSENSE WEBSTER, INC. P990071 S032 09/16/2015
EPT-1000 CARDIAC ABLATION SYSTEM Boston Scientific Corp. P920047 S084 09/15/2015
CHILLI II COOLED ABLATION SYSTEM Boston Scientific Corp. P980003 S063 09/15/2015
FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),F... Abbott Medical P110016 S022 09/14/2015
THERAPY COOL FLEX AND FLEXABILITY ABLATION CATHETE... Abbott Medical P110016 S020 09/02/2015
RF CONTACTR, RF ENHANCR II, RF MARINR, RF CONDUCTR... MEDTRONIC Inc. P930029 S053 09/02/2015
LIVEWIRE TC ABLATION CATHETER St. Jude Medical P960016 S055 08/31/2015
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