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ABBOTT MEDICAL

3,576 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS (P030035/S007)ABBOTT MEDICAL2006-03-14
MICRONY PACEMAKERS (P970013/S004)ABBOTT MEDICAL2006-03-14
EPIC/EPIC+ AND ATLAS/ATLAS+ FAMILY OF PULSE GENERATORS (P910023/S101)ABBOTT MEDICAL2006-03-14
SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y (P880086/S114)ABBOTT MEDICAL2006-03-14
EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE (P030054/S019)ABBOTT MEDICAL2006-03-14
EPIC HF & ATLAS + HF (P030054/S022)ABBOTT MEDICAL2006-03-07
VARIOUS MODELS OF SYNCHRONY TRILOGY AND AFFINITY FAMILY OF PACEMAKERS (P880086/S115)ABBOTT MEDICAL2006-03-07
EPIC,EPIC+,ATLAS+, ATLAS, PHOTON MICRO,PHOTON, ICD'S (P910023/S100)ABBOTT MEDICAL2006-03-07
MICRONY PACEMAKERS (P970013/S005)ABBOTT MEDICAL2006-03-07
RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012 (P950022/S027)ABBOTT MEDICAL2006-03-07
RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052 (P950022/S028)ABBOTT MEDICAL2006-03-07
FRONTIER CRT-P (P030035/S008)ABBOTT MEDICAL2006-03-07
MICRONY/REGENCY AND FRONTIER (P030054/S020)ABBOTT MEDICAL2006-03-02
GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES (P030035/S006)ABBOTT MEDICAL2006-03-02
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S092)ABBOTT MEDICAL2006-03-02
TENDRILL MODEL 1488T/TC AND 1688T/TC LEADS (P960013/S017)ABBOTT MEDICAL2006-03-02
FRONTIER II DEVICE MODEL 5586 (P030035/S010)ABBOTT MEDICAL2006-03-02
MICRONY PULSE GENERATORS (P970013/S003)ABBOTT MEDICAL2006-03-02
IMPLANTABLE PACEMAKERS (P880086/S113)ABBOTT MEDICAL2006-03-02
TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS (P960013/S016)ABBOTT MEDICAL2006-03-02
QUICKSITE MODEL 1056K LEAD (P030054/S021)ABBOTT MEDICAL2006-02-24
THE AMPLATZER SEPTAL OCCLUDER (P000039/S015)ABBOTT MEDICAL2006-02-22
PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S095)ABBOTT MEDICAL2006-02-16
ST JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM (P910023/S094)ABBOTT MEDICAL2006-02-16
PHOTON MICRO & ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S097)ABBOTT MEDICAL2006-02-16
QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD (P030054/S018)ABBOTT MEDICAL2006-02-15
IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE (P880086/S111)ABBOTT MEDICAL2006-02-08
TACHYCARDIA DEFIBRILLATOR DEVICES (P910023/S089)ABBOTT MEDICAL2006-02-08
TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC (P960013/S015)ABBOTT MEDICAL2006-02-07
AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S006)ABBOTT MEDICAL2006-02-06
AMPLATZER DUCT OCCLUDER AND AMPLATZER 180 DEGREE DELIVERY AND EXCHANGE SYSTEM (P020024/S008)ABBOTT MEDICAL2006-02-06
IDENTITY/IDENTITY ADX, INTEGRITY, AFFINITY, AND ENTITY PULSE GENERATOR MODELS (P880086/S110)ABBOTT MEDICAL2006-01-31
PHOTON, EPIC AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S090)ABBOTT MEDICAL2006-01-20
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS (P910023/S091)ABBOTT MEDICAL2006-01-10
GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S018)ABBOTT MEDICAL2005-12-21
ST.JUDE MEDICAL ICDS/CRT-DS (P030054/S011)ABBOTT MEDICAL2005-12-16
ST.JUDE MEDICAL ICDS/CRT-D (P910023/S080)ABBOTT MEDICAL2005-12-16
VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610 (P880086/S108)ABBOTT MEDICAL2005-12-07
AMPLATZER DUCT OCCLUDER (P020024/S009)ABBOTT MEDICAL2005-11-30
ST JUDES MEDICAL ICDS AND CRT-DS (P030054/S014)ABBOTT MEDICAL2005-11-28
ST JUDES MEDICAL ICD (P910023/S085)ABBOTT MEDICAL2005-11-28
PHOTON, EPIC, AND ATLAS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND CARDIAC RESYNCHRONIZATION THERAPY (P910023/S087)ABBOTT MEDICAL2005-11-18
PHOTON, EPIC, AND ATLAS FAMILIES OF ICDS AND CRT-DS (P030054/S017)ABBOTT MEDICAL2005-11-18
EPIC AND ATLAS+ HF CRT-D SYSTEMS (P030054/S010)ABBOTT MEDICAL2005-11-18
GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S017)ABBOTT MEDICAL2005-11-16
AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES (P030054/S015)ABBOTT MEDICAL2005-11-15
ST.JUDE MEDICAL RIATA/ RIATA I DEFIBRILLATION LEADS (P950022/S025)ABBOTT MEDICAL2005-11-04
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) (P030054/S013)ABBOTT MEDICAL2005-11-02
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CARDIAC RESYNCHRONIZATION THERAPY DEVICES (ICD AND CRT-DS) (P910023/S084)ABBOTT MEDICAL2005-11-02
ICD/CRT-D (P030054/S012)ABBOTT MEDICAL2005-10-17
ISOFLEX S LEAD MODEL 1646T (P960030/S013)ABBOTT MEDICAL2005-10-17
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICES (ICD AND CRT-D) (P910023/S083)ABBOTT MEDICAL2005-10-17
AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P880086/S109)ABBOTT MEDICAL2005-10-14
AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE (P000039/S010)ABBOTT MEDICAL2005-10-13
AMPLATZER DUCT OCCLUDER (P020024/S005)ABBOTT MEDICAL2005-10-13
MERLIN PATIENT CARE SYSTEM MODEL 3650 (P030054/S008)ABBOTT MEDICAL2005-10-12
AMPLATZER DUCT OCCLUDER (P000039/S007)ABBOTT MEDICAL2005-09-16
AMPLATZER DUCT OCCLUDER (P020024/S002)ABBOTT MEDICAL2005-09-16
EPIC AND ATLAS FAMILIES OF DEVICES (P950022/S026)ABBOTT MEDICAL2005-09-13
AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES (P880086/S105)ABBOTT MEDICAL2005-08-25
AFFINITY, IDENTITY, INTEGRITY, AND FRONTIER FAMILY OF DEVICES (P880086/S106)ABBOTT MEDICAL2005-08-25
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021)ABBOTT MEDICAL2005-08-05
PULSE GENERATOR (P880086/S104)ABBOTT MEDICAL2005-07-08
ISOFLEX S PERMANENT PACING LEAD MODELS PASSIVE PLUS DX (P960030/S011)ABBOTT MEDICAL2005-06-29
ATLAS AND ATLAS+ IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P030054/S007)ABBOTT MEDICAL2005-06-17
ICD FIRMWARE VERSION 6.6.7 FOR EPIC, EPIC +, ATLAS AND ATLAS +, AND MODEL 3307 PROGRAMMER SOFTWARE VERSION 4.8.5 (P910023/S077)ABBOTT MEDICAL2005-06-17
RIATA ST LEAD MODELS 7000, 7001, AND 7002 (P950022/S024)ABBOTT MEDICAL2005-06-03
HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-R RECEIVER SOFTWARE (VERSION 2.1) (P910023/S078)ABBOTT MEDICAL2005-05-24
RIATA DEFIBRILLATION LEADS (P950022/S019)ABBOTT MEDICAL2005-05-16
GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S013)ABBOTT MEDICAL2005-05-11
DUAL CHAMBER IMPLANTABLE CARDIOVERTER (P030054/S009)ABBOTT MEDICAL2005-05-09
CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S079)ABBOTT MEDICAL2005-05-09
RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S022)ABBOTT MEDICAL2005-05-05
GENESIS DUAL 4-CHANNEL IMPLANTABLE PULSE GENERATOR (IPG) (P010032/S016)ABBOTT MEDICAL2005-05-05
RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S021)ABBOTT MEDICAL2005-05-05
RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S020)ABBOTT MEDICAL2005-05-05
RIATA FAMILY OF DEFIBRILLATION LEADS (P950022/S023)ABBOTT MEDICAL2005-05-05
FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (P030035/S003)ABBOTT MEDICAL2005-04-29
ISOFLEX P LEAD FAMILY MODELS 1644T AND 1648T STEROID ELUTING, PASSIVE FIXATION ENDOCARDIAL PACING LEADS (P960030/S012)ABBOTT MEDICAL2005-04-27
QUICKSITE 1056T LEFT VENTRICULAR PACING LEAD (P030054/S004)ABBOTT MEDICAL2005-04-11
PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380, (P880086/S103)ABBOTT MEDICAL2005-04-06
EPIC, EPIC+, AND EPIC HE ICD SYSTEMS (P030054/S006)ABBOTT MEDICAL2005-03-30
EPIC HF & ATLAS + HF CRT-D SYSTEMS (P030054/S005)ABBOTT MEDICAL2005-03-08
SYCHRONY PULSE GENERATOR (P880086/S102)ABBOTT MEDICAL2005-03-08
GENESIS NEUROSTIMULATION SYSTEM (P010032/S014)ABBOTT MEDICAL2005-03-04
EPIC AND EPIC+ DR/VR ICD SYSTEMS WITH N2 CAPACITOR (P910023/S076)ABBOTT MEDICAL2005-03-01
SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) (P810002/S058)ABBOTT MEDICAL2005-02-14
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S075)ABBOTT MEDICAL2005-01-19
FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM (P030035/S002)ABBOTT MEDICAL2005-01-14
ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P030054/S002)ABBOTT MEDICAL2005-01-14
IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS (P880086/S101)ABBOTT MEDICAL2004-11-22
ST. JUDE MEDICAL EPIC HF DEFIBRILLATOR MODEL V-337, ST. JUDE MEDICAL ATLAS+ HF DEFIBRILLATOR MODEL V-343 (P030054/S001)ABBOTT MEDICAL2004-11-17
GENESIS NEUROSTIMULATION SYSTEM (P010032/S012)ABBOTT MEDICAL2004-11-09
EPIC HF CRT-D (P030054/S003)ABBOTT MEDICAL2004-10-25
FRONTIER II BIVENTRICULAR PULSE GENERATOR WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE (P030035/S001)ABBOTT MEDICAL2004-08-16
MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS (P880086/S100)ABBOTT MEDICAL2004-07-21
ST JUDE MEDICAL EPIC HF SYSTEM (P030054)ABBOTT MEDICAL2004-06-30
ANTHEM AND FRONTIER II CRT-P'S (P030035)ABBOTT MEDICAL2004-05-13
HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS (P910023/S073)ABBOTT MEDICAL2004-05-12
GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S011)ABBOTT MEDICAL2004-05-05
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