Microport Crm S R L

FDA Filings

This page includes the latest FDA filings for Microport Crm S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1000165971
• FEI Number: 1000165971
• Name: MicroPort CRM S.r.l.
• Owner & Operator: MicroPort CRM S.R.L.
• Contact Address: 5640 Airline Road Regulatory Affairs, c/o David Thierman; Arlington TN 38002 US
• Official Correspondent:
  • Kathy - Vittum
  • 01-651-2386017-x
• US Agent:
  • Kathy Vittum
  • MicroPort CRM USA, Inc.
  • 651 2386017
  • 651 9250119
  • Kathy.vittum@crm.microport.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via Crescentino s.n ; Saluggia (VC) Vercelli, 13040 IT
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08031527019833 MICROPORT CRM SRL	Vega RLK42U	2023-07-04
GUDID 08031527019826 MICROPORT CRM SRL	Vega RLK41U	2023-07-04
GUDID 08031527019819 MICROPORT CRM SRL	Vega RLK40U	2023-07-04
GUDID 08031527019611 MICROPORT CRM SRL	CPR4 B10031	2023-07-04
GUDID 08031527021188 MICROPORT CRM SRL	RMS RMS	2023-07-03
GUDID 08031527021089 MICROPORT CRM SRL	SmartView SmartView 3.14	2023-07-03
GUDID 08031527019932 MICROPORT CRM SRL	SmartView SW001U	2023-07-03
GUDID 08031527019802 MICROPORT CRM SRL	Vega TLD042U	2023-07-03
GUDID 08031527019796 MICROPORT CRM SRL	Vega TLD041U	2023-07-03
GUDID 08031527019789 MICROPORT CRM SRL	Vega TLD040U	2023-07-03
GUDID 08031527019024 MICROPORT CRM SRL	BlueSky TPM025U	2023-07-03
GUDID 08031527019017 MICROPORT CRM SRL	BlueSky TPM024U	2023-07-03
GUDID 08031527019000 MICROPORT CRM SRL	BlueSky TPM021U	2023-07-03
GUDID 08031527018997 MICROPORT CRM SRL	BlueSky TPM020U	2023-07-03
GUDID 08031527017334 MICROPORT CRM SRL	Smart ECG K379	2021-10-22
GUDID 08031527017020 MICROPORT CRM SRL	USB adapter for CPR3H G999	2021-10-22
GUDID 08031527017013 MICROPORT CRM SRL	CPR3H GB78	2021-10-22
GUDID 08031527019956 MICROPORT CRM SRL	Magnet TAC004C	2021-10-01
GUDID 08031527018089 MICROPORT CRM SRL	Smart Spot with CPR4BR accessory KC861	2021-09-30
GUDID 08031527017877 MICROPORT CRM SRL	SmartView monitor KC961	2021-09-30
GUDID 08031527017754 MICROPORT CRM SRL	CPR4BR accessory B10000	2021-09-30
GUDID 08031527017174 MICROPORT CRM SRL	Smartview	2020-10-20
GUDID 08031527016788 MICROPORT CRM SRL	SMARTVIEW	2020-10-20
GUDID 08031527016375 MICROPORT CRM SRL	SMARTVIEW	2020-10-20
GUDID 08031527016023 MICROPORT CRM SRL	SPIDERVIEW	2020-10-20
GUDID 08031527015569 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015538 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015521 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015514 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015484 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015477 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015460 MICROPORT CRM SRL	PLATINIUM	2020-10-20
GUDID 08031527015095 MICROPORT CRM SRL	SPIDERVIEW	2020-10-20
GUDID 08031527015088 MICROPORT CRM SRL	SPIDERVIEW	2020-10-20
GUDID 08031527015071 MICROPORT CRM SRL	SPIDERVIEW	2020-10-20
GUDID 08031527015064 MICROPORT CRM SRL	SPIDERVIEW	2020-10-20
GUDID 08031527015057 MICROPORT CRM SRL	SPIDERVIEW / SPIDERFLASH	2020-10-20
GUDID 08031527015040 MICROPORT CRM SRL	SYNESCOPE	2020-10-20
GUDID 08031527015033 MICROPORT CRM SRL	SYNESCOPE	2020-10-20
GUDID 08031527014944 MICROPORT CRM SRL	EASYSCOPE	2020-10-20
GUDID 08031527014913 MICROPORT CRM SRL	EASYSCOPE	2020-10-20
GUDID 08031527014654 MICROPORT CRM SRL	Remote Monitoring System	2020-10-20
GUDID 08031527014647 MICROPORT CRM SRL	Smartview Hotspot	2020-10-20
GUDID 08031527014630 MICROPORT CRM SRL	Smartview Hotspot	2020-10-20
GUDID 08031527014487 MICROPORT CRM SRL	Smartview	2020-10-20
GUDID 08031527014296 MICROPORT CRM SRL	EASYSCOPE	2020-10-20
GUDID 08031527014289 MICROPORT CRM SRL	SYNESCOPE	2020-10-20
GUDID 08031527014210 MICROPORT CRM SRL	ORCHESTRA PLUS LINK	2020-10-20
GUDID 08031527013916 MICROPORT CRM SRL	ECG Cable	2020-10-20
GUDID 08031527013909 MICROPORT CRM SRL	ECG Cable	2020-10-20
GUDID 08031527013893 MICROPORT CRM SRL	Remote Monitoring System	2020-10-20
GUDID 08031527013886 MICROPORT CRM SRL	Smartview	2020-10-20
GUDID 08031527013435 MICROPORT CRM SRL	SYNECOM	2020-10-20
GUDID 08031527013381 MICROPORT CRM SRL	Smartview Monitor	2020-10-20
GUDID 08031527013374 MICROPORT CRM SRL	Smartview Monitor	2020-10-20
GUDID 08031527013367 MICROPORT CRM SRL	Orchestra	2020-10-20
GUDID 08031527013350 MICROPORT CRM SRL	CPR3	2020-10-20
GUDID 08031527012834 MICROPORT CRM SRL	Intensia	2020-10-20
GUDID 08031527012827 MICROPORT CRM SRL	Intensia	2020-10-20
GUDID 08031527012810 MICROPORT CRM SRL	Intensia	2020-10-20
GUDID 08031527012278 MICROPORT CRM SRL	Paradym RF	2020-10-20
GUDID 08031527012261 MICROPORT CRM SRL	Paradym RF	2020-10-20
GUDID 08031527012254 MICROPORT CRM SRL	Paradym RF	2020-10-20
GUDID 08031527012247 MICROPORT CRM SRL	Reply	2020-10-20
GUDID 08031527011523 MICROPORT CRM SRL	Reply	2020-10-20
GUDID 08031527009629 MICROPORT CRM SRL	Screwdriver	2020-10-20
GUDID 08031527009230 MICROPORT CRM SRL	Screwdriver	2020-10-20
GUDID 08031527009162 MICROPORT CRM SRL	Esprit	2020-10-20
GUDID 08031527009056 MICROPORT CRM SRL	Esprit	2020-10-20
PMN K042002 | DQK MicroPort CRM S.r.l.	Synescope	2011-01-14
PMN K042002 | DQK MicroPort CRM S.r.l.	Synecom	2011-01-14
PMN K042002 | DQK MicroPort CRM S.r.l.	Holter reader	2011-01-14
PMN K042002 | DQK MicroPort CRM S.r.l.	Easyscope	2011-01-14
PMN K032466 | MWJ MicroPort CRM S.r.l.	Spiderview	2011-01-14
PMN P980049 | OSR MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	Paradym VR 8250	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	Paradym RF VR 9250	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	Paradym RF DR 9550	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	Paradym DR 8550	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	PLATINIUM VR 1240	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	PLATINIUM VR 1210	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	PLATINIUM DR 1540	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	PLATINIUM DR 1510	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	Orchestra Programmer	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	Orchestra Plus Programmer	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	INTENSIA VR 124	2009-08-31
PMN P980049 | OSR MicroPort CRM S.r.l.	INTENSIA DR 154	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	Paradym VR 8250	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	Paradym RF VR 9250	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	Paradym RF DR 9550	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	Paradym DR 8550	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	PLATINIUM VR 1240	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	PLATINIUM VR 1210	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	PLATINIUM DR 1540	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	PLATINIUM DR 1510	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	Orchestra Programmer	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	Orchestra Plus Programmer	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	INTENSIA VR 124	2009-08-31
PMN P980049 | NVN MicroPort CRM S.r.l.	INTENSIA DR 154	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	Paradym VR 8250	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	Paradym RF VR 9250	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	Paradym RF DR 9550	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	Paradym DR 8550	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	PLATINIUM VR 1240	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	PLATINIUM VR 1210	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	PLATINIUM DR 1540	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	PLATINIUM DR 1510	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	Orchestra Programmer	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	Orchestra Plus Programmer	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	INTENSIA VR 124	2009-08-31
PMN P980049 | MRM MicroPort CRM S.r.l.	INTENSIA DR 154	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	Paradym VR 8250	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	Paradym RF VR 9250	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	Paradym RF DR 9550	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	Paradym DR 8550	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	PLATINIUM VR 1240	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	PLATINIUM VR 1210	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	PLATINIUM DR 1540	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	PLATINIUM DR 1510	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	Orchestra Programmer	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	Orchestra Plus Programmer	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	INTENSIA VR 124	2009-08-31
PMN P980049 | LWS MicroPort CRM S.r.l.	INTENSIA DR 154	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	Paradym VR 8250	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	Paradym RF VR 9250	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	Paradym RF DR 9550	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	Paradym DR 8550	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	PLATINIUM VR 1240	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	PLATINIUM VR 1210	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	PLATINIUM DR 1540	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	PLATINIUM DR 1510	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	Orchestra Programmer	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	Orchestra Plus Programmer	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	INTENSIA VR 124	2009-08-31
PMN P980049 | DXY MicroPort CRM S.r.l.	INTENSIA DR 154	2009-08-31
PMN P060027 | OSR MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	SMARTVIEW Home Monitor	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	Paradym RF CRT-D Model 9750	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	Paradym CRT-D Model 8750	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	PLATINIUM CRT-D 1741	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	PLATINIUM CRT-D 1711	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	PLATINIUM 4LV CRT-D 1744	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	ORCHESTRA Plus Link	2009-08-26
PMN P060027 | OSR MicroPort CRM S.r.l.	INTENSIA CRT-D 174	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	SMARTVIEW Home Monitor	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	Paradym RF CRT-D Model 9750	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	Paradym CRT-D Model 8750	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	PLATINIUM CRT-D 1741	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	PLATINIUM CRT-D 1711	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	PLATINIUM 4LV CRT-D 1744	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	ORCHESTRA Plus Link	2009-08-26
PMN P060027 | OJX MicroPort CRM S.r.l.	INTENSIA CRT-D 174	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	SMARTVIEW Home Monitor	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	Paradym RF CRT-D Model 9750	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	Paradym CRT-D Model 8750	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	PLATINIUM CRT-D 1741	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	PLATINIUM CRT-D 1711	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	PLATINIUM 4LV CRT-D 1744	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	ORCHESTRA Plus Link	2009-08-26
PMN P060027 | NIK MicroPort CRM S.r.l.	INTENSIA CRT-D 174	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	SMARTVIEW Home Monitor	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	Paradym RF CRT-D Model 9750	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	Paradym CRT-D Model 8750	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	PLATINIUM CRT-D 1741	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	PLATINIUM CRT-D 1711	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	PLATINIUM 4LV CRT-D 1744	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	ORCHESTRA Plus Link	2009-08-26
PMN P060027 | LWS MicroPort CRM S.r.l.	INTENSIA CRT-D 174	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	SMARTVIEW Home Monitor	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	Paradym RF CRT-D Model 9750	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	Paradym CRT-D Model 8750	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	PLATINIUM CRT-D 1741	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	PLATINIUM CRT-D 1711	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	PLATINIUM 4LV CRT-D 1744	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	ORCHESTRA Plus Link	2009-08-26
PMN P060027 | DXY MicroPort CRM S.r.l.	INTENSIA CRT-D 174	2009-08-26
PMN P950029 | NVZ MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	Reply SR	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	Reply DR	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	Esprit SR	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	Esprit DR	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	CPR3 wand	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	Accessory for pacemaker, ICD and CRT-D Screw driver	2009-08-21
PMN P950029 | NVZ MicroPort CRM S.r.l.	Accessory for pacemaker, ICD and CRT-D Permanent magnet	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	Reply SR	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	Reply DR	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	Esprit SR	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	Esprit DR	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	CPR3 wand	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	Accessory for pacemaker, ICD and CRT-D Screw driver	2009-08-21
PMN P950029 | LWP MicroPort CRM S.r.l.	Accessory for pacemaker, ICD and CRT-D Permanent magnet	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	SMARTVIEW Hotspot Brady Remote Monitoring System	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	Reply SR	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	Reply DR	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	Esprit SR	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	Esprit DR	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	CPR3 wand	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	Accessory for pacemaker, ICD and CRT-D Screw driver	2009-08-21
PMN P950029 | DXY MicroPort CRM S.r.l.	Accessory for pacemaker, ICD and CRT-D Permanent magnet	2009-08-21

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• MicroPort CRM USA Inc.5640 Airline Roadarlington, TN 38002 PMA NumberP980049 Supplement NumberS143 Date Received07/20/2022 Decision Date07/28/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No