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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 63 Results
productcode LPB PMA Number p Decision Date From 1/1/2013 Decision Date To 1/1/2014
 
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Device
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PMA
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7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMIS... BIOSENSE WEBSTER, INC. P040036 S036 05/29/2013
7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM... BIOSENSE WEBSTER, INC. P030031 S052 05/29/2013
7F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP... BIOSENSE WEBSTER, INC. P990025 S037 05/29/2013
BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S... Biosense Webster, Inc P950005 S041 06/06/2013
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S024 09/05/2013
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S022 04/25/2013
BIOSENSE WEBSTER CELSIUS FLTR CATHETER Biosense Webster, Inc P950005 S048 11/26/2013
BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CA... Boston Scientific Corp. P920047 S054 01/22/2013
BLAZER II CARDIAC ABLATION CATHETER AND CABLE Boston Scientific Corp. P920047 S061 10/18/2013
BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II... Boston Scientific Corp. P920047 S058 07/22/2013
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