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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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PMA
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BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION ... BOSTON SCIENTIFIC P020025 S051 12/18/2013
THERAPY COOL FLEX ABLATION CATHETER Abbott Medical P110016 S008 12/18/2013
MAESTRO 3000 CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S049 12/05/2013
INTELLA TIP MIFI XP ABLATION CATHETER BOSTON SCIENTIFIC P020025 S050 12/03/2013
CELSIUS FLTR CATHETERS BIOSENSE WEBSTER, INC. P010068 S037 11/26/2013
EPT-1000 XP RF ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S045 11/25/2013
EPT-1000 XP RF ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S046 11/25/2013
BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND... BOSTON SCIENTIFIC P020025 S048 10/23/2013
BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE BOSTON SCIENTIFIC P020025 S047 10/18/2013
EPT-1000XP CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S044 10/07/2013
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