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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 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 Boston Scientific Corp. P980003 S062 08/19/2015
THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P030031 S070 08/18/2015
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S052 08/18/2015
CELSIUS FLTR UNI -DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S058 08/18/2015
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P030031 S069 08/06/2015
THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P040036 S051 08/06/2015
THERAPY ABLATION CATHETER IRVINE BIOMEDICAL, INC. P040014 S024 07/09/2015
THERAPY COOL PATH ABLATION CATHETER IRVINE BIOMEDICAL, INC. P060019 S030 07/09/2015
SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS Abbott Medical P110016 S014 07/09/2015
FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIO... Abbott Medical P110016 S018 07/09/2015
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