Product Code: MRM


Products Classified as MRM

1037Defibrillator, Implantable, Dual-chamber

Total Product Life Cycle (TPLC) Devices

1037Defibrillator, Implantable, Dual-chamber

FDA Consensus Standards

Defibrillator, Implantable, Dual-Chamber [36797]21 CFR Unclassified 🔎
Defibrillator, Implantable, Dual-Chamber [37688]21 CFR Unclassified 🔎
Defibrillator, Implantable, Dual-Chamber [31693]21 CFR Unclassified 🔎

Pre-market Approvals for MRM

P000009PSW 1803.U / HMSC 3.40.2 /CardioMessenger SmartBIOTRONIK, INC.
P050023Defibrillator, Implantable Cardioverter, with Cardiac Resynchronization (Crt-D); Defibrillator, Implantable, Dual-ChambeBIOTRONIK, INC.
P980049Implantable Cardioverter Defibrillator ICDsMicroPort CRM USA Inc.

Global Unique Device Identification Database

04035479156947DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479156848DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479156749DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479156992DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479156893DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479156794DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479156695DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479142100DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479142094DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479136260DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479136246DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479128944DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479128920DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479128913DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
04035479128906DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Maude Adverse Events

RIVACOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-31
ITREVIA 5 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-26
IFORIA 5 DR-T PROMRI DF-1BIOTRONIK SE & CO. KG2020-03-25
PARADYM RFSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-25
PARADYMSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-23
ACTICOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-23
ILIVIA 7 DR-T DF-1 PROMRIBIOTRONIK SE & CO. KG2020-03-23
ITREVIA 5 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-20
RIVACOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-20
IPERIA 7 DR-T DF-1 PROMRIBIOTRONIK SE & CO. KG2020-03-19
SORIN OVATIO ICD VR-IMPLANTEDSORIN CRM SAS2020-03-17
PARADYMSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-13
LUMAX 740 DR-TBIOTRONIK SE & CO. KG2020-03-12
ILIVIA 7 DR-T DF-1 PROMRIBIOTRONIK SE & CO. KG2020-03-09
PARADYMSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-09
ISOLINESORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-09
ILIVIA 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-06
RIVACOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-03
ILIVIA 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-03-02
ITREVIA 5 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-02-26
ISOLINESORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-26
LUMAX 540 DR-TBIOTRONIK SE & CO. KG2020-02-25
ISOLINESORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-25
IPERIA 7 DR-T DF-1 PROMRIBIOTRONIK SE & CO. KG2020-02-20
LUMAX 740 DR-TBIOTRONIK SE & CO. KG2020-02-19
IFORIA 3 DR-T DF4BIOTRONIK SE & CO. KG2020-02-19
IFORIA 5 DR-T PROMRI DF4BIOTRONIK SE & CO. KG2020-02-18
PLATINIUMSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-16
ILIVIA 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-02-14
PLATINIUMSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-13
LUMAX 740 DR-TBIOTRONIK SE & CO. KG2020-02-12
LUMAX 740 DR-TBIOTRONIK SE & CO. KG2020-02-10
IFORIA 5 DR-T PROMRI DF-1BIOTRONIK SE & CO. KG2020-02-07
ILIVIA 7 DR-T DF-1 PROMRIBIOTRONIK SE & CO. KG2020-02-07
IFORIA 5 DR-T PROMRI DF4BIOTRONIK SE & CO. KG2020-02-06
INLEXA 3 VR-T DF-1BIOTRONIK SE & CO. KG2020-02-06
PLATINIUMSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-04
PARADYM RFSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-04
ORCHESTRASORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-02-03
RIVACOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-01-31
LUMAX 540 DR-TBIOTRONIK SE & CO. KG2020-01-30
ILIVIA 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-01-28
ILIVIA 7 DR-T DF-1 PROMRIBIOTRONIK SE & CO. KG2020-01-28
ACTICOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-01-23
ILESTO 7 DR-T DF-1BIOTRONIK SE & CO. KG2020-01-23
PARADYM RFSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-01-21
ILIVIA 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-01-21
IFORIA 3 DR-T DF4BIOTRONIK SE & CO. KG2020-01-16
RIVACOR 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-01-16
ILIVIA 7 DR-T DF4 PROMRIBIOTRONIK SE & CO. KG2020-01-15

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