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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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productcode OAD PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
 
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THERAPY COOL PATH DUO AND SAFIRE BLU DUO ABLATION ... Abbott Medical P110016 S009 09/27/2013
THERAPY COOL FLEX ABLATION CATHETER Abbott Medical P110016 S008 12/18/2013
SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERIS... Abbott Medical P110016 S007 08/29/2013
BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABL... Abbott Medical P110016 S006 04/18/2013
THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CAT... Abbott Medical P110016 S003 07/30/2013
THERAPY COOL PATH ABLATION CATHETERS IRVINE BIOMEDICAL, INC. P060019 S024 09/27/2013
THERAPY DUAL 8 ABLATION CATHETERS IRVINE BIOMEDICAL,INC.(IBI) P040042 S025 09/27/2013
BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION ... BOSTON SCIENTIFIC P020025 S051 12/18/2013
INTELLA TIP MIFI XP ABLATION CATHETER BOSTON SCIENTIFIC P020025 S050 12/03/2013
MAESTRO 3000 CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S049 12/05/2013
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