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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 38 Results
productcode LPB PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
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Device
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PMA
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BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER Boston Scientific Corp. P920047 S053 09/21/2012
THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCO... BIOSENSE WEBSTER, INC. P030031 S047 09/20/2012
SAFIRE ABLATION SYSTEM St. Jude Medical P960016 S039 09/10/2012
CRYOABLATION CONSOLE Medtronic CryoCath LP P020045 S044 08/24/2012
THERAPY CARDIAC ABLATION SYSTEM IRVINE BIOMEDICAL, INC. P040014 S019 08/22/2012
CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHET... Biosense Webster, Inc P950005 S039 07/25/2012
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHE... BIOSENSE WEBSTER, INC. P990025 S033 07/25/2012
STOCKERT RADIOFREQUENCY GENERATOR BIOSENSE WEBSTER, INC. P990071 S019 07/25/2012
CELSIUS THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S043 07/23/2012
STINGER, STINGER S, STINGER M, STINGER SM, SCORPIO... Boston Scientific Corp. P000020 S015 07/12/2012
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