Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008159616

FEI Number

3008159616

Entity Name

Sorin CRM SAS

City/State/Country

CLAMART Hauts-de-Seine, FR

Establishment Address

4, avenue Reaumur, CLAMART Hauts-de-Seine 92140, FR

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MicroPort CRM USA, Inc. (Owner Number: 2182863)

Owner / Operator Contact Address

5677 Airline Road, Regulatory Affairs, c/o Dwyndl Nelms, Arlington, TN 38002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P980049

All Registered Proprietary Names

Easyscope Synescope Synecom HRV Holter reader Synecom Accessory for pacemaker, ICD and CRT-D Permanent magnet Reply SR Reply DR CPR3 telemetry wand (Accessory to SmartView Hotspot) Esprit DR SMARTVIEW Hotspot Brady Remote Monitoring System Accessory for pacemaker, ICD and CRT-D Screw driver Esprit SR CPR4BR telemetry wand (Accessory to Smart Spot) Smart Spot (Brady home monitor) SmartView Connect App (V1) ALIZEA DR 1600 CELEA SR 1100 ALIZEA SR 1300 CELEA DR 1400 Holter cables Spiderview Spiderview plus Paradym RF CRT-D 9750 SMARTVIEW Home Monitor SMARTVIEW Hotspot Brady Remote Monitoring System Intensia CRT-D 174 ORCHESTRA Plus Link PLATINIUM CRT-D 1711 PLATINIUM CRT-D 1741 PLATINIUM 4LV CRT-D 1744 Paradym CRT-D 8750 Smart Monitor (Home monitor) Magnet Paradym RF DR 9550 Paradym VR 8250 SMARTVIEW Home Monitor Intensia VR 124 Paradym DR 8550 Paradym RF VR 9250 PLATINIUM VR 1240 Intensia DR 154 PLATINIUM DR 1510 PLATINIUM DR 1540 PLATINIUM VR 1210 Accessory for pacemaker, ICD and CRT-D Screw driver Orchestra Plus Programmer Smart Monitor CPR4 Remote Monitoring Software SmartTouch Programmer Software (SmartView)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-01-14
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2011-01-06
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2011-01-06
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2011-01-06
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2011-01-14
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2011-01-06
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2011-01-06
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2011-01-06
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2011-01-06
DTG	Magnet, Test, Pacemaker	Cardiovascular	Class 1	870.3690	2021-09-21
MRM	Defibrillator, Implantable, Dual-Chamber	Unknown	Class 3	N/A	2011-01-06
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2011-01-06
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2011-01-06
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2011-01-06

Official Correspondent

John Skousen

US Agent Details

John Skousen Business: MICROPORT CRM USA, INC. Email: john.skousen@crm.microport.com Phone: (801) 3864437

Related Public Records

Same Entity

MicroPort CRM USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011181002	Sorin Group DR S.r.l.	Santo Domingo, DO

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008159616. Last updated year: 2026. Please use registration number 3008159616 when referencing this establishment in official correspondence.