FDA.reportPublic FDA data

RHYTHMIA HDx™

Primary DI
00191506020804
Brand
RHYTHMIA HDx™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004RA65010
Catalog number
M004RA65010
Device description
Ablation Connection Box (for INTELLAGEN™)
Published
2024-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPBCardiac ablation percutaneous catheter
OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020025141
P150005079
P920047133

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020025141EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P150005079BLAZER OPEN-IRRIGATED ABLATION CATHETERBoston Scientific Corp2016-02-24OAD
P920047133EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506020804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506020804001915060208041915060208040191506020804

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping systemAn assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
04044508136966MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137048iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152225MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
04044508136959MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137031iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152218MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-08
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2025-08-30
00763000995003N/AMEDTRONIC, INC.OAD2025-04-12
20763000995007N/AMEDTRONIC, INC.OAD2025-04-12
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAD2025-01-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAD2024-12-06
00763000871772NAMEDTRONIC, INC.OAD2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAD2024-11-04
20763000871776NAMEDTRONIC, INC.OAD2024-11-04
00763000871802NAMEDTRONIC, INC.OAD2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAD2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAD2024-11-04