FDA.reportPublic FDA data

INGEVITY™ MRI

Primary DI
00802526523397
Brand
INGEVITY™ MRI
Company
BOSTON SCIENTIFIC CORPORATION
Model
7736
Device description
Pace/Sense Lead
Published
2016-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
P150012000
P150012031
P150012032
P150012060
P150012070
P150012139
P150012176
P150012180

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150012000IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012031IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012032IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012060IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012070IMAGEREADY 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
P150012176IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP
P150012180IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADBoston Scientific2016-04-25LWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526523397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526523397008025265233978025265233970802526523397

GMDN Terms#

Term, Definition table
TermDefinition
Endocardial/interventricular septal pacing leadAn implantable 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 transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
106295384
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729860853Expel™ Drainage Catheter with Twist-Loc™ HubH74939341082502016-08-17
08714729860860Expel™ Drainage Catheter with Twist-Loc™ HubH74939341102502016-08-17
08714729860877Expel™ Drainage Catheter with Twist-Loc™ HubH74939341122502016-08-17
08714729860884Expel™ Drainage Catheter with Twist-Loc™ HubH74939341142502016-08-17
08714729860891Expel™ Drainage Catheter with Twist-Loc™ HubH749393410825K12016-08-17
08714729860907Expel™ Drainage Catheter with Twist-Loc™ HubH749393411025K12016-08-17
08714729860914Expel™ Drainage Catheter with Twist-Loc™ HubH749393411225K12016-08-17
00802526623400NA694669462024-08-29
00802526604430INGEVITY™+78402020-02-06
00802526604522INGEVITY™+78422020-02-06
00802526604577INGEVITY™+78412020-02-06
00802526480546NA662866282014-09-24
00802526488900NA60402014-09-24
00802526488924NA60422014-09-24
00802526488931NA60432014-09-24
00802526496868RELIANCE 4-FRONT™06362018-08-25
00802526496967RELIANCE 4-FRONT™06652018-08-25
00802526496981RELIANCE 4-FRONT™06752018-08-25
00802526497001RELIANCE 4-FRONT™06762018-08-25
00802526523304INGEVITY™ MRI77312016-05-10

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
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