FDA.reportPublic FDA data

Vega

Primary DI
08031527019789
Brand
Vega
Company
MICROPORT CRM SRL
Model
TLD040U
Catalog number
TLD040U
Device description
VEGA R 45D MRI
Published
2023-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130010000
P950029127

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130010000VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)MicroPort CRM USA, Inc.2023-05-17NVN
P950029127CHORUS 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
08031527019789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527019789080315270197898031527019789

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial pacing leadAn implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Excursion permitted to 0-50°C
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
438860859
Device count
1
Combination product
true
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
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
08031527021089SmartViewSmartView 3.14SmartView 3.142023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479177041Solia CSP S 60BIOTRONIK SE & Co. KGNVN2026-02-17
04035479177058Solia CSP S 53BIOTRONIK SE & Co. KGNVN2026-02-17
05415067055507Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067055514Zenex MRI™ST. JUDE MEDICAL, INC.NVN2026-01-22
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.NVN2025-02-11
08031527019819VegaMICROPORT CRM SRLNVN2023-06-26
08031527019826VegaMICROPORT CRM SRLNVN2023-06-26
08031527019833VegaMICROPORT CRM SRLNVN2023-06-26
08031527019796VegaMICROPORT CRM SRLNVN2023-06-23
08031527019802VegaMICROPORT CRM SRLNVN2023-06-23
05415067046314UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046321UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046338UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
05415067046345UltiPace™ST. JUDE MEDICAL, INC.NVN2023-06-13
00763000740252SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
00763000740276SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2022-12-11
05415067037275NAST. JUDE MEDICAL, INC.NVN2022-01-07
00763000316778Adapta™MEDTRONIC, INC.NVN2020-11-28
00802526604430INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604522INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00802526604577INGEVITY™+BOSTON SCIENTIFIC CORPORATIONNVN2020-02-06
00763000130794SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVN2018-10-11