FDA.reportPublic FDA data

RESONATE™ HF ICD VR

Primary DI
00802526588280
Brand
RESONATE™ HF ICD VR
Company
BOSTON SCIENTIFIC CORPORATION
Model
D532
Device description
Implantable Cardioverter Defibrillator VR
Published
2021-07-12
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
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960040385
P960040390
P960040395
P960040438
P960040459
P960040484

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960040385VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMBoston Scientific1997-07-18LWS
P960040390VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMBoston Scientific1997-07-18LWS
P960040395VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMBoston Scientific1997-07-18LWS
P960040438VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMBoston Scientific1997-07-18LWS
P960040459VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMBoston Scientific1997-07-18LWS
P960040484VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEMBoston Scientific1997-07-18LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526588280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526588280008025265882808025265882800802526588280

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable defibrillatorAn implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526625008ACUITY™706070602026-10-15
08714729748861RX Cholangiogram KitM005711502016-09-24
08714729748878RX Cholangiogram KitM005711602016-09-24
08714729749097RX Cholangiogram KitM005714002016-09-24
08714729749110RX Cholangiogram KitM005714202016-09-24
08714729749257RX Cholangiogram KitM005715602016-09-24
08714729749295RX Cholangiogram KitM005716002016-09-24
08714729749332RX Cholangiogram KitM005716402016-09-24
08714729749394RX Cholangiogram KitM005717002016-09-24
08714729749509RX Cholangiogram KitM005718102016-09-24
08714729749615RX Cholangiogram KitM005719202016-09-24
00191506065577Ranger™H74939501400470H749395014004702026-10-14
00191506065584Ranger™H74939501400670H749395014006702026-10-14
00191506065591Ranger™H74939501400870H749395014008702026-10-14
00191506065607Ranger™H74939501401070H749395014010702026-10-14
00191506065614Ranger™H74939501401270H749395014012702026-10-14
00191506065621Ranger™H74939501401570H749395014015702026-10-14
00191506065638Ranger™H74939501402070H749395014020702026-10-14
00191506065645Ranger™H74939501400410H749395014004102026-10-14
00191506065652Ranger™H74939501400610H749395014006102026-10-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479182793Rivacor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182830Acticor Sky VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479182847Acticor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183011Rivacor Aura VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183059Rivacor Rise VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183066Rivacor Rise VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479185695Rivacor Aura VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
05415067049575Merlin™ST. JUDE MEDICAL, INC.LWS2025-06-25
05414734500586NAST. JUDE MEDICAL, INC.LWS2025-05-07
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05415067050052Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWS2024-11-13
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.LWS2024-11-04
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00802526623400NABOSTON SCIENTIFIC CORPORATIONLWS2024-08-29
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05415067049421Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049469Entrant™ST. JUDE MEDICAL, INC.LWS2024-04-25
05415067049476Gallant™ST. JUDE MEDICAL, INC.LWS2024-04-25
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