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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode OAD PMA Number p Decision Date From 1/1/2008 Decision Date To 1/1/2009
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Device
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PMA
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THERAPY DUAL 8 ABLATION CATHETERS IRVINE BIOMEDICAL,INC.(IBI) P040042 S014 12/10/2008
THERAPY COOL PATH ABLATION CATHETERS IRVINE BIOMEDICAL, INC. P060019 S007 12/10/2008
NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP ... BIOSENSE WEBSTER, INC. P010068 S013 11/07/2008
BLAZER II XP CATHETERS BOSTON SCIENTIFIC P020025 S019 06/13/2008
THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9... IRVINE BIOMEDICAL, INC. P060019 S004 06/13/2008
THERAPY DUAL 8, THERAPY & SAFIRE TX ABLATION CATHE... IRVINE BIOMEDICAL,INC.(IBI) P040042 S012 06/09/2008
CRYOCOR CRYOABLATION SYSTEM Boston Scientific Corp. P050024 S001 03/13/2008
EZ STEER 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS BIOSENSE WEBSTER, INC. P010068 S012 02/01/2008
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