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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode OAE PMA Number p Decision Date From 1/1/2012 Decision Date To 1/1/2013
 
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ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER... Medtronic CryoCath LP P100010 S021 11/20/2012
ARCTIC FRONT CARDIAC CYROABLATION CATHETER, ARCT... Medtronic CryoCath LP P100010 S020 11/07/2012
ARCTIC FRONT CARDIAC CRYOABLATION CATHETERS Medtronic CryoCath LP P100010 S019 10/10/2012
UNIDIRECTIONAL THERMOCOOL SF NAV CATHETER BIOSENSE WEBSTER, INC. P030031 S045 10/02/2012
CRYOBLATION CONSOLE Medtronic CryoCath LP P100010 S018 09/21/2012
CRYOABLATION CONSOLE Medtronic CryoCath LP P100010 S017 08/24/2012
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER Medtronic CryoCath LP P100010 S015 04/12/2012
AORTIC FRONT CARDIAC CRYOABLATION CATHETERS Medtronic CryoCath LP P100010 S016 04/04/2012
THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL C... BIOSENSE WEBSTER, INC. P030031 S038 03/23/2012
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER Medtronic CryoCath LP P100010 S014 02/09/2012
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