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MicroPort CRM USA, Inc.

413 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P980049/S146)MicroPort CRM USA, Inc.2025-11-25
ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P130010/S002)MicroPort CRM USA, Inc.2025-11-25
ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P060027/S106)MicroPort CRM USA, Inc.2025-11-25
VEGA R45; VEGA R52; VEGA R58; VEGA R45 RE-INTERVENTION KIT; VEGA R58 RE-INTERVENTION KIT; VEGA R45 RE-INTERVENTION KIT (P130010/S004)MicroPort CRM USA, Inc.2025-07-23
Platinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR (P980049/S147)MicroPort CRM USA, Inc.2025-07-23
Platinium CRT-D 1711; Platinium CRT-D 1741; Platinium 4LV CRT-D 1744; ENERGYA CRT-D 3711; ENERGYA CRT-D 3741; ENERGYA 4L (P060027/S107)MicroPort CRM USA, Inc.2025-07-23
Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400 (P950029/S134)MicroPort CRM USA, Inc.2025-07-23
Vega Endocardial Pacing Leads (P130010/S003)MicroPort CRM USA, Inc.2025-04-15
Vega Endocardial Pacing Leads (P130010/S001)MicroPort CRM USA, Inc.2024-02-02
Programming software modules for Orchestra Plus and SmartTouch programmers, Remote monitoring software (P980049/S145)MicroPort CRM USA, Inc.2023-05-17
ALIZEA and CELEA pacemakers, Remote monitoring software (RMS) (P950029/S133)MicroPort CRM USA, Inc.2023-05-17
ALIZEA and CELEA pacemakers, Remote monitoring software (RMS) (P950029/S132)MicroPort CRM USA, Inc.2023-05-17
Programming software modules for Orchestra Plus and SmartTouch programmers, CPR4 Telemetry head accessory for SmartTouch (P980049/S144)MicroPort CRM USA, Inc.2023-05-17
ALIZEA SR/DR and CELEA SR/DR 1.5T and 3T Full Body MRI conditional pacemakers (P950029/S127)MicroPort CRM USA, Inc.2023-05-17
VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58) (P130010)MicroPort CRM USA, Inc.2023-05-17
Smartview Connect remote monitoring solution (P980049/S139)MicroPort CRM USA, Inc.2023-05-17
Orchestra, Orchestra Plus, and SmartTouch programming software modules (P980049/S143)MicroPort CRM USA, Inc.2022-07-28
Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P060027/S105)MicroPort CRM USA, Inc.2021-08-13
Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P950029/S129)MicroPort CRM USA, Inc.2021-08-13
Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot (P980049/S141)MicroPort CRM USA, Inc.2021-08-13
Orchestra, Orchestra Plus, and Smart Touch programmers (P980049/S142)MicroPort CRM USA, Inc.2021-06-25
Alizea and Celea Pacemakers (P950029/S130)MicroPort CRM USA, Inc.2021-06-25
Reply SR, Reply DR (P950029/S131)MicroPort CRM USA, Inc.2021-03-10
Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG (P980049/S137)MicroPort CRM USA, Inc.2021-02-18
Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) and Orchestra Plus Link (P980049/S140)MicroPort CRM USA, Inc.2020-10-20
Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator) (P060027/S104)MicroPort CRM USA, Inc.2020-10-20
Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers (P950029/S128)MicroPort CRM USA, Inc.2020-10-20
Platinium VR and Platinium DR ICDs (P980049/S138)MicroPort CRM USA, Inc.2020-08-10
Reply SR and Reply DR Pacemakers (P950029/S126)MicroPort CRM USA, Inc.2020-08-10
Platinium CRT-D and Platinium 4LV CRT-D (P060027/S103)MicroPort CRM USA, Inc.2020-08-10
Cardiac Resynchronization Therapy-Defibrillator (CRT-D) (P060027/S101)MicroPort CRM USA, Inc.2020-06-24
Implantable Cardioverter Defibrillator (ICD) (P980049/S135)MicroPort CRM USA, Inc.2020-06-24
Reply SR and Reply DR Pacemakers (P950029/S125)MicroPort CRM USA, Inc.2020-03-26
Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator) (P060027/S102)MicroPort CRM USA, Inc.2020-03-06
Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) (P980049/S136)MicroPort CRM USA, Inc.2020-03-06
Reply SR and Reply DR Pacemakers (P950029/S124)MicroPort CRM USA, Inc.2020-03-06
Platinium 4LV CRT-D (P060027/S100)MicroPort CRM USA, Inc.2019-12-04
Reply/Esprit (5th generation) Electric Hybrid Module (P950029/S123)MicroPort CRM USA, Inc.2019-07-29
PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; (P980049/S133)MicroPort CRM USA, Inc.2019-03-19
PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; (P060027/S098)MicroPort CRM USA, Inc.2019-03-19
Implantable Cardioverter Defibrillator ICDs (P980049/S134)MicroPort CRM USA, Inc.2019-03-05
Cardiac Resynchronization Therapy Defibrillator (P060027/S099)MicroPort CRM USA, Inc.2019-03-05
CRT-Ds (Cardiac Resynchronization Therapy Defibrillator) Platinium (P060027/S097)MicroPort CRM USA, Inc.2018-12-06
ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR (P980049/S132)MicroPort CRM USA, Inc.2018-12-06
Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia CRT-D, Platinium CRT-D, Platinium 4LV CRT-D (P060027/S096)MicroPort CRM USA, Inc.2018-05-14
Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S122)MicroPort CRM USA, Inc.2018-05-14
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR (P980049/S131)MicroPort CRM USA, Inc.2018-05-14
Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S121)MicroPort CRM USA, Inc.2018-04-25
Paradym RF CRT-d 9750, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium 4 LV CRT-D 1744 (P060027/S095)MicroPort CRM USA, Inc.2018-04-25
Paradym RF VR 9250, Paradym RF DR 9550, Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540 (P980049/S130)MicroPort CRM USA, Inc.2018-04-25
Platinium CRT-D 1741; Platinium 4LV CRT-D 1744 (P060027/S094)MicroPort CRM USA, Inc.2018-03-20
Platinium VR 1240; Platinium DR 1540 (P980049/S129)MicroPort CRM USA, Inc.2018-03-20
Pacemakers Reply SR/DR and Esprit SR/DR (P950029/S120)MicroPort CRM USA, Inc.2018-03-15
PLATINIUM 4LV CRT-D (P060027/S093)MicroPort CRM USA, Inc.2018-03-11
Reply SR / Esprit SR / Reply DR / Esprit DR (P950029/S118)MicroPort CRM USA, Inc.2018-03-11
PLATINIUM VR / DR / CRT-D (P980049/S128)MicroPort CRM USA, Inc.2018-03-11
REPLY & ESPRIT SR & DR Pacemakers (P950029/S117)MicroPort CRM USA, Inc.2018-01-29
Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S119)MicroPort CRM USA, Inc.2018-01-29
Cardiac Resynchronization Therapy Defibrillator CRT-Ds (P060027/S092)MicroPort CRM USA, Inc.2018-01-25
Implantable Cardioverter Defibrillator ICDs (P980049/S127)MicroPort CRM USA, Inc.2018-01-25
PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (IS1) and 1744 (IS4) (P060027/S088)MicroPort CRM USA, Inc.2017-10-26
PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (P980049/S123)MicroPort CRM USA, Inc.2017-10-26
Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S116)MicroPort CRM USA, Inc.2017-09-07
Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5) (P950029/S114)MicroPort CRM USA, Inc.2017-08-03
SMARTVIEW hotspot ; Orchestra Plus Link (P060027/S091)MicroPort CRM USA, Inc.2017-07-27
SMARTVIEW hotspot (P950029/S115)MicroPort CRM USA, Inc.2017-07-27
SMARTVIEW hotspot; Orchestra Plus Link (P980049/S126)MicroPort CRM USA, Inc.2017-07-27
Paradym and Paradym RF, Update to Platinium Embedded Software (P980049/S125)MicroPort CRM USA, Inc.2017-07-26
Paradym and Paradym RF, Update to Platinium Embedded Software (P060027/S090)MicroPort CRM USA, Inc.2017-07-26
Platinium CRT-Ds (Cardiac Resynchronization Therapy-Defibrillator) (P060027/S089)MicroPort CRM USA, Inc.2017-03-20
Platinium VR and Platinium DR ICD's (Implantable Cardioverter Defobrillator) (P980049/S124)MicroPort CRM USA, Inc.2017-03-20
Reply/Esprit Pacemakers Sorin CRM. (P950029/S113)MicroPort CRM USA, Inc.2016-12-16
Repy SR/DR & Esprit SR/DR Pacemakers (P950029/S112)MicroPort CRM USA, Inc.2016-10-25
REPLY/ESPRIT PACEMAKER IMPLANTABLE DEVICES (P980049/S118)MicroPort CRM USA, Inc.2016-10-04
Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DR (P980049/S117)MicroPort CRM USA, Inc.2016-09-27
Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds (P060027/S083)MicroPort CRM USA, Inc.2016-09-27
Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemakers (P950029/S111)MicroPort CRM USA, Inc.2016-09-27
ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540. (P980049/S122)MicroPort CRM USA, Inc.2016-09-21
CRT-Ds (Cardiac Resynchronization Therapy Defibrillator),Platinium CRT-D 1711, 01741 (P060027/S087)MicroPort CRM USA, Inc.2016-09-21
Paradym VR, DR,Paradym RF VR, Paradym RF DR (ZL101),(ZL102),Intensia VR, Intensia DR,Platinium VR 1210, Platinium VR 124 (P980049/S120)MicroPort CRM USA, Inc.2016-09-20
Paradym CRT-D; Paradym RF CRT-D (ZL101),(ZL102); Intensia CRT-D; Platinium CRT-D 1711,1741. (P060027/S085)MicroPort CRM USA, Inc.2016-09-20
Platinum VR and DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD's (P980049/S119)MicroPort CRM USA, Inc.2016-09-07
Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD) (P980049/S121)MicroPort CRM USA, Inc.2016-09-07
Platinium CRT-D 1711, 1741. (P060027/S086)MicroPort CRM USA, Inc.2016-09-07
Platinum CARDIAC RESYNCHRONIZATION THERAPY DEFBRILLATOR CRT's (P060027/S084)MicroPort CRM USA, Inc.2016-09-07
PLATINIUM CRT-D 1711/1741 (P060027/S081)MicroPort CRM USA, Inc.2016-08-09
PLATINIUM VR 1210/1240, PLATINIUM DR 1510/1540 (ICD) (P980049/S115)MicroPort CRM USA, Inc.2016-08-09
Platinium CRT-D 1711; Platinium CRT-D 1741 (P060027/S082)MicroPort CRM USA, Inc.2016-08-08
Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540 (P980049/S116)MicroPort CRM USA, Inc.2016-08-08
PLATINIUM CRT-D (MODELS 1711 AND 1741) (P060027/S079)MicroPort CRM USA, Inc.2016-07-07
PLATINIUM VR (MODELS 1210 AND 1240) AND PLATINIUM DR (MODELS 1510 AND 1540) ICDS (P980049/S113)MicroPort CRM USA, Inc.2016-07-07
REPLY DR, REPLY SR, ESPRIT DR, ESPRIT SR (P950029/S105)MicroPort CRM USA, Inc.2016-06-24
ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER (P980049/S109)MicroPort CRM USA, Inc.2016-06-24
REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers (P950029/S110)MicroPort CRM USA, Inc.2016-06-22
PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101),PARADYM RF VR 9750, PARADYM RF DR 9750(ZL10 (P980049/S114)MicroPort CRM USA, Inc.2016-05-11
REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S108)MicroPort CRM USA, Inc.2016-05-11
PARADYM CRT-D 8750,PARADYM RF CRT-D 9750(ZL101),PARADYM RF CRT-D 9750(ZL102),INTENSIA CRT-D (P060027/S080)MicroPort CRM USA, Inc.2016-05-11
Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S109)MicroPort CRM USA, Inc.2016-03-01
SMARTVIEW REMOTE MONITORING SYSTEM (P980049/S105)MicroPort CRM USA, Inc.2015-09-16
SMARTVIEW REMOTE MONITORING SYSTEM (P060027/S072)MicroPort CRM USA, Inc.2015-09-16
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Every clearance here is in the API, with alerts when new ones post.