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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 20 Results
productcode LPB PMA Number p Decision Date From 1/1/2008 Decision Date To 1/1/2009
 
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NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CAT... BIOSENSE WEBSTER, INC. P990025 S016 11/07/2008
EZ STEER 4MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS BIOSENSE WEBSTER, INC. P990025 S015 02/01/2008
CHILLI COOLED ABLATION CATHETER Boston Scientific Corp. P980003 S021 09/19/2008
CHILLI II COOLED ABLATION SYSTEM Boston Scientific Corp. P980003 S018 06/13/2008
LIVEWIRE TC CARDIAC ABLATION SYSTEM St. Jude Medical P960016 S022 02/22/2008
EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTION... Biosense Webster, Inc P950005 S024 02/01/2008
STEEROCATH T CARDIAC ABLATION CATHETER Boston Scientific Corp. P920047 S038 10/10/2008
BLAZER II CARDIAC ABLATION CATHETERS Boston Scientific Corp. P920047 S037 06/13/2008
HELIOS II ABLATION CATHETER STEREOTAXIS, INC. P050029 10/10/2008
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERA... BIOSENSE WEBSTER, INC. P040036 S009 11/07/2008
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