FDA.reportPublic FDA data

Esprit

Primary DI
08031527009056
Brand
Esprit
Company
MICROPORT CRM SRL
Model
DR
Published
2014-09-05
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
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950029079
P950029098
P950029099
P950029105

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950029079CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERMicroPort CRM USA, Inc.1997-03-10DXY
P950029098CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERMicroPort CRM USA, Inc.1997-03-10DXY
P950029099CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERMicroPort CRM USA, Inc.1997-03-10DXY
P950029105CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERMicroPort CRM USA, Inc.1997-03-10DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031527009056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527009056080315270090568031527009056

GMDN Terms#

Term, Definition table
TermDefinition
Dual-chamber implantable pacemaker, rate-responsiveA sterile, battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.

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
00763000812058NAMEDTRONIC, INC.NVZ2025-04-12
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NVZ2024-11-13
00763000378356Instrument Command LibraryMEDTRONIC, INC.NVZ2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.NVZ2024-05-04
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000612665MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000688400CareLink SmartSync™MEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NVZ2022-10-28
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000181345NAMEDTRONIC, INC.NVZ2021-06-12
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2021-02-25
00763000414023MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414030MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414047MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316723Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316730Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.NVZ2020-11-28
00763000316761Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316778Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316785Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316792Adapta™MEDTRONIC, INC.NVZ2020-11-28