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MicroPort CRM USA, Inc.

413 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1 (P900022/S012)MicroPort CRM USA, Inc.2009-02-04
SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD (P060027/S008)MicroPort CRM USA, Inc.2009-02-04
ISOLINE 2CR/2CT DEFIBRILLATION LEADS (P980049/S044)MicroPort CRM USA, Inc.2009-02-04
SYMPHONY SR/DR & RHAPSODY SR/DR (P950029/S039)MicroPort CRM USA, Inc.2009-02-04
OVATIO CRT 6750 (P060027/S005)MicroPort CRM USA, Inc.2009-02-03
OVATIO VR 6250 & DR 6550 (P980049/S041)MicroPort CRM USA, Inc.2009-02-03
ISOLINE 2CR, ISOLINE 2CT STEROID ELUTING PACING LEADS (P980049/S043)MicroPort CRM USA, Inc.2008-12-10
OVATIO VR 6250 & DR 6550 ICDS (P980049/S029)MicroPort CRM USA, Inc.2008-12-05
OVATIO VR & DR ICDS (P980049/S036)MicroPort CRM USA, Inc.2008-11-06
OVATIO CRT-D SYSTEM (P060027/S002)MicroPort CRM USA, Inc.2008-10-31
OVATIO VR 6250 AND OVATIO DR 6550 (P980049/S040)MicroPort CRM USA, Inc.2008-10-31
OVATIO CRT 6750 (P060027/S004)MicroPort CRM USA, Inc.2008-10-31
STELID II, STELIX, AND STLIX II STEROID-ELUTING PACING LEADS (P020030/S004)MicroPort CRM USA, Inc.2008-10-17
OVATIO VR/DR (P980049/S042)MicroPort CRM USA, Inc.2008-10-17
OVATIO CRT (P060027/S006)MicroPort CRM USA, Inc.2008-10-17
SYMPHONY SR/DR & RHAPSODY SR/DR (P950029/S038)MicroPort CRM USA, Inc.2008-10-17
ISOLINE 2CR (P980049/S039)MicroPort CRM USA, Inc.2008-10-09
PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS (P980049/S037)MicroPort CRM USA, Inc.2008-09-10
OVATIO CRT-D SYSTEM (P060027/S001)MicroPort CRM USA, Inc.2008-09-10
CHORUS PACEMAKERS (P900022/S011)MicroPort CRM USA, Inc.2008-09-10
VARIOUS FAMILIES OF PACEMAKERS (P950029/S036)MicroPort CRM USA, Inc.2008-09-10
REPLY PACEMAKERS (P950029/S032)MicroPort CRM USA, Inc.2008-07-25
SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR (P950029/S037)MicroPort CRM USA, Inc.2008-07-23
OVATIO VR & DR (P980049/S038)MicroPort CRM USA, Inc.2008-07-23
OVATIO CRT (P060027/S003)MicroPort CRM USA, Inc.2008-07-23
OVATIO CRT SYSTEM (P060027)MicroPort CRM USA, Inc.2008-05-15
OVATIO DR & OVATIO VR ICDS (P980049/S034)MicroPort CRM USA, Inc.2008-04-25
OVATIO VR & DR ICDS (P980049/S032)MicroPort CRM USA, Inc.2008-03-20
OVATIO VR & DR ICDS (P980049/S031)MicroPort CRM USA, Inc.2008-03-20
OVATIO VR & DR ICDS (P980049/S033)MicroPort CRM USA, Inc.2008-03-20
OVATIO VR & DR ICDS (P980049/S030)MicroPort CRM USA, Inc.2008-03-20
SMARTVIEW (P980049/S035)MicroPort CRM USA, Inc.2008-03-18
SMARTVIEW (P950029/S034)MicroPort CRM USA, Inc.2008-03-18
SMARTVIEW (P900022/S010)MicroPort CRM USA, Inc.2008-03-18
SYMPHONY & ELA RHAPSODY PACEMAKERS (P950029/S033)MicroPort CRM USA, Inc.2008-02-13
ISOLINE 2CR DEFIBRILLATION LEADS (P980049/S021)MicroPort CRM USA, Inc.2008-01-15
ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7 (P980049/S024)MicroPort CRM USA, Inc.2008-01-09
ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049/S028)MicroPort CRM USA, Inc.2007-11-13
ALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS (P950029/S031)MicroPort CRM USA, Inc.2007-11-13
ALL NON-RATE RESPONSIVE PACEMAKERS (P900022/S009)MicroPort CRM USA, Inc.2007-11-13
OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6260 (P980049/S027)MicroPort CRM USA, Inc.2007-10-23
ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE (P950029/S030)MicroPort CRM USA, Inc.2007-06-29
ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE (P900022/S008)MicroPort CRM USA, Inc.2007-06-29
ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE (P980049/S025)MicroPort CRM USA, Inc.2007-06-29
OVATIO DR 6550 & OVATIO VR 6250 DEVICES (P980049/S026)MicroPort CRM USA, Inc.2007-05-18
RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS (P950029/S029)MicroPort CRM USA, Inc.2006-09-22
SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210 (P950029/S028)MicroPort CRM USA, Inc.2006-09-15
SYMPHONY & ELA RHAPSODY DEVICES (P950029/S027)MicroPort CRM USA, Inc.2006-09-15
NON-RATE RESPONSIVE PACEMAKERS (P900022/S007)MicroPort CRM USA, Inc.2006-07-26
RATE RESPONSIVE PACEMAKERS (P950029/S026)MicroPort CRM USA, Inc.2006-07-26
ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE FOR CHORUS MODELS 6001, 6003, 6004, 6033, AND 6034 (P980049/S023)MicroPort CRM USA, Inc.2006-07-26
STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D (P020030/S003)MicroPort CRM USA, Inc.2006-07-12
OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD (P980049/S020)MicroPort CRM USA, Inc.2006-04-28
VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER (P980049/S022)MicroPort CRM USA, Inc.2006-03-15
CHORUS & OPUS RATE-RESPONSIVE PACEMAKERS (P900022/S006)MicroPort CRM USA, Inc.2006-03-15
VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS (P950029/S025)MicroPort CRM USA, Inc.2006-03-15
STELIX II ENDOCARDIAL PACING LEADS (P020030/S002)MicroPort CRM USA, Inc.2005-12-29
SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER (P950029/S024)MicroPort CRM USA, Inc.2005-09-02
ALTO SHOCK 4 MODULES (P980049/S019)MicroPort CRM USA, Inc.2005-05-13
SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE (P950029/S022)MicroPort CRM USA, Inc.2005-04-27
ELA MEDICAL RATE-RESPONSIVE PACEMAKERS (P950029/S023)MicroPort CRM USA, Inc.2005-02-28
ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980049/S018)MicroPort CRM USA, Inc.2005-02-28
ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA (P980049/S017)MicroPort CRM USA, Inc.2004-12-08
STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS (P020030/S001)MicroPort CRM USA, Inc.2004-11-22
ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980049/S016)MicroPort CRM USA, Inc.2004-11-17
SYMPHONY & ELA RHAPSODY PACEMAKERS (P950029/S021)MicroPort CRM USA, Inc.2004-10-27
SYMPHONY AND ELA RHAPSODY PACEMAKERS (P950029/S020)MicroPort CRM USA, Inc.2004-07-15
STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD (P020030)MicroPort CRM USA, Inc.2004-06-17
ORCHESTRA PROGRAMMER (P980049/S015)MicroPort CRM USA, Inc.2004-05-04
ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 (P980049/S014)MicroPort CRM USA, Inc.2004-04-15
ORCHESTRA PROGRAMMER (P980049/S013)MicroPort CRM USA, Inc.2004-03-16
ALTO DR MODEL 614, ALTO VR MODEL 615, ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 (P980049/S012)MicroPort CRM USA, Inc.2004-03-15
SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3) (P950029/S019)MicroPort CRM USA, Inc.2004-02-13
SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM (P950029/S017)MicroPort CRM USA, Inc.2003-10-24
ORCHESTRA PROGRAMMER (P980049/S011)MicroPort CRM USA, Inc.2003-10-21
ORCHESTRA PROGRAMMER (P980049/S010)MicroPort CRM USA, Inc.2003-10-14
ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS (P980049/S009)MicroPort CRM USA, Inc.2003-07-02
SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD (P980049/S008)MicroPort CRM USA, Inc.2003-02-14
TALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR133 (P950029/S016)MicroPort CRM USA, Inc.2002-12-18
ORCHESTRA PROGRAMMER (P980049/S007)MicroPort CRM USA, Inc.2002-01-11
ALTO ICD MODELS 614 AND 615 (P980049/S006)MicroPort CRM USA, Inc.2001-12-21
TALENT AND BRIO PACEMAKERS (P950029/S015)MicroPort CRM USA, Inc.2001-11-26
TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG (P950029/S014)MicroPort CRM USA, Inc.2001-07-03
ORCHESTRA PROGRAMMER (P980049/S005)MicroPort CRM USA, Inc.2001-06-08
LYRA(TM) ICD SYSTEMS (P970024/S004)MicroPort CRM USA, Inc.2001-02-06
BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE (P950029/S013)MicroPort CRM USA, Inc.2001-02-02
ORCHESTRA PROGRAMMER (P980049/S004)MicroPort CRM USA, Inc.2001-01-31
ALTO DR ICD (P980049/S003)MicroPort CRM USA, Inc.2000-12-14
ORCHESTRA PROGRAMMER (P980049/S002)MicroPort CRM USA, Inc.2000-11-13
ELA RATE-RESPONSIVE PACEMAKERS (P950029/S011)MicroPort CRM USA, Inc.2000-10-11
TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR) (P950029/S010)MicroPort CRM USA, Inc.2000-10-10
ELA RATE-RESPONSIVE PACEMAKERS (P950029/S012)MicroPort CRM USA, Inc.2000-09-13
TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER (P950029/S006)MicroPort CRM USA, Inc.2000-05-18
DEFENDER IV MODEL 612 DUAL-CHAMBER, RATE-RESPONSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, ELA MEDICAL PROMGRAMMER (P980049/S001)MicroPort CRM USA, Inc.2000-05-18
MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS (P950029/S008)MicroPort CRM USA, Inc.1999-12-03
PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG) (P950029/S009)MicroPort CRM USA, Inc.1999-11-19
BRIO CARDIAC PACEMAKERS (P950029/S007)MicroPort CRM USA, Inc.1999-09-16
DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049)MicroPort CRM USA, Inc.1999-09-15
ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT (P970024/S003)MicroPort CRM USA, Inc.1999-09-14
BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE (P950029/S005)MicroPort CRM USA, Inc.1999-08-25
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