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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 174 Results
productcode LWS PMA Number p Decision Date From 1/1/2014 Decision Date To 1/1/2015
 
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Device
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PMA
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LUMOS FAMILY OF ICD'S BIOTRONIK, INC. P000009 S056 06/20/2014
XELOS DR-T ICD'S BIOTRONIK, INC. P000009 S057 05/04/2014
BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR... BIOTRONIK, INC. P000009 S058 11/17/2014
ICS 3000/ RENAMIC PROGRAMMERS BIOTRONIK, INC. P000009 S059 10/21/2014
BRAVA CRT-D, CONCERTO ICD,CONCERTO II CRT-D,CONSUL... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S439 05/29/2014
BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D MEDTRONIC CARDIAC RHYTHM DISEA P010031 S440 05/23/2014
, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, ... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S466 11/14/2014
CONCERTO II CRT-D, CONCULTA CRT-D, MAXIMO II CRT-D... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S467 10/02/2014
LUMAX 6/7 AND ILESTO/IFORIA ICD/CRT D FAMILIES BIOTRONIK, INC. P050023 S075 03/11/2014
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYS... BOSTON SCIENTIFIC CORPORATION P110042 S017 04/02/2014
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