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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 85 Results
productcode LPB PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
 
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PMA
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FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTR... Medtronic CryoCath LP P020045 S069 12/31/2015
FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; F... Abbott Medical P110016 S028 12/21/2015
CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CAT... BIOSENSE WEBSTER, INC. P030031 S059 12/17/2015
EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV ... BIOSENSE WEBSTER, INC. P040036 S044 12/17/2015
BLAZER PRIME HTD, BLAZER II, BLAZER II HTD Boston Scientific Corp. P920047 S087 12/17/2015
BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS... Biosense Webster, Inc P950005 S051 12/17/2015
BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NA... BIOSENSE WEBSTER, INC. P990025 S040 12/17/2015
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S028 12/17/2015
FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , F... Abbott Medical P110016 S026 12/11/2015
LIVEWIRE TC CARDIAC ABLATION SYSTEM St. Jude Medical P960016 S058 11/17/2015
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