FDA.reportPublic FDA data

INGEVITY™+

Primary DI
00802526604522
Brand
INGEVITY™+
Company
BOSTON SCIENTIFIC CORPORATION
Model
7842
Device description
Pace/Sense Lead
Published
2020-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
P150012083
P150012139
P150012158

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150012083IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012139IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012158IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526604522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526604522008025266045228025266045220802526604522

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial pacing leadA sterile, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length59Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106295384
Device count
1
Combination product
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

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
08031527019789VegaMICROPORT CRM SRLNVN2023-06-23
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
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