FDA.reportPublic FDA data

Intensia

Primary DI
08031527012827
Brand
Intensia
Company
MICROPORT CRM SRL
Model
DR 154
Published
2015-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRMDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRMDefibrillator, Implantable, Dual-ChamberUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980049099
P980049103

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980049099DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATORMicroPort CRM USA, Inc.1999-09-15MRM
P980049103DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATORMicroPort CRM USA, Inc.1999-09-15MRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031527012827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527012827080315270128278031527012827

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable defibrillatorAn implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate and to pace the heart in cases of bradycardia. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on two same-side heart chambers (atrium and ventricle) to monitor the ECG and to automatically deliver the electrical impulse. The device has internal batteries that provide the energy to deliver the impulses; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
438860859
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08031527013909ECG Cable4,5m2014-09-05
08031527013916ECG Cable3m2014-09-05
08031527015057SPIDERVIEW / SPIDERFLASH2 Leads / 3E2016-09-22
08031527015064SPIDERVIEWXYZ-HR / 7E2016-09-22
08031527015071SPIDERVIEW12 Leads / 10 E2016-09-22
08031527015088SPIDERVIEW2 Leads / 5 E2016-09-22
08031527015095SPIDERVIEW3 Leads XYZ / 7E2016-09-22
08031527016023SPIDERVIEW7 leads2016-09-22
08031527019789VegaTLD040UTLD040U2023-06-23
08031527019796VegaTLD041UTLD041U2023-06-23
08031527019802VegaTLD042UTLD042U2023-06-23
08031527019611CPR4B10031B100312023-06-26
08031527019819VegaRLK40URLK40U2023-06-26
08031527019826VegaRLK41URLK41U2023-06-26
08031527019833VegaRLK42URLK42U2023-06-26
08031527018997BlueSkyTPM020UTPM020U2023-06-23
08031527019000BlueSkyTPM021UTPM021U2023-06-23
08031527019017BlueSkyTPM024UTPM024U2023-06-23
08031527019024BlueSkyTPM025UTPM025U2023-06-23
08031527019932SmartViewSW001USW001U2023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479182755Rivacor Sky DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479182823Acticor Sky DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479183004Rivacor Aura DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479183042Rivacor Rise DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
08031527019611CPR4MICROPORT CRM SRLMRM2023-06-26
08031527017334Smart ECGMICROPORT CRM SRLMRM2021-10-14
04035479156749Ilivia Neo 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156848Intica Neo 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156947Intica Neo 5 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156695Acticor 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156794Rivacor 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156893Rivacor 5 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156992Rivacor 3 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479142094Ilivia 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2018-12-13
04035479142100Ilivia 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2017-05-18
08031527015460PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015477PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015514PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015521PLATINIUMMICROPORT CRM SRLMRM2016-09-09
04035479128777Iperia 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2016-01-07
04035479128913Iperia 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2016-01-07
08031527014654Remote Monitoring SystemMICROPORT CRM SRLMRM2015-10-05
08031527012834IntensiaMICROPORT CRM SRLMRM2015-02-20
04035479128784Iperia 7 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128807Itrevia 7 DR-T DF-1BIOTRONIK SE & Co. KGMRM2015-02-18
04035479128838Iperia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128852Itrevia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128883Iperia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128906Itrevia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128920Iperia 7 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18