FDA.reportPublic FDA data

nGEN Generator

Primary DI
10846835018080
Brand
nGEN Generator
Company
Biosense Webster Inc
Model
D138402
Catalog number
D138402
Device description
Generator
Published
2022-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
LPBCardiac ablation percutaneous catheter
OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2
LPBCardiac Ablation Percutaneous CatheterUnknown3
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterUnknown3
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010068067
P030031122
P040036084
P950005082
P990025067
P990071051

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010068067NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETERBiosense Webster, Inc.2002-09-27OAD
P030031122BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSBiosense Webster, Inc.2004-11-05OAD
P040036084NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERBiosense Webster, Inc.2006-08-11LPB
P950005082WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERBiosense Webster, Inc.1997-09-30LPB
P990025067NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERBiosense Webster, Inc.2000-06-15DRF
P990071051STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORBiosense Webster, Inc.2000-05-31LPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846835018080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683501808010846835018080

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac radio-frequency ablation system generatorAn electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Regulatory Flags#

DUNS number
020163218
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835008883CARTO 3D128622D1286222016-09-16
10846835008838SOUNDSTAR10438577104385772016-09-16
10846835009798THERMOCOOL SMARTTOUCH SFD134703D1347032016-11-11
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyD142902D1429022023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyD142901D1429012023-10-04
10846835017427TX eco CableD140102D1401022023-07-21
10846835016710QDOT MICROD139501D1395012023-07-07
10846835016727QDOT MICROD139502D1395022023-07-07
10846835016734QDOT MICROD139503D1395032023-07-07
10846835016741QDOT MICROD139504D1395042023-07-07
10846835016758QDOT MICROD139505D1395052023-07-07
10846835017045QDOT MICROD139401D1394012023-07-07
10846835017076QDOT MICROD139402D1394022023-07-07
10846835017106QDOT MICROD139403D1394032023-07-07
10846835021110OCTARAY Mapping CatheterD160902D1609022021-10-14
10846835021127OCTARAY Mapping CatheterD160903D1609032021-10-14
10846835021134OCTARAY Mapping CatheterD160906D1609062021-10-14
10846835021141OCTARAY Mapping CatheterD160901D1609012021-10-14

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Primary DI, Brand, Company table
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00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
04044508136966MAGIC - iCONNECTOSYPKA GmbHLPB2026-03-13
04044508137048iCONNECT - AMPEREOSYPKA GmbHLPB2026-03-13
04044508152225MAGiC Magnetic Interventional Ablation CatheterOSYPKA GmbHLPB2026-03-13
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAD2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-08
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00763000995003N/AMEDTRONIC, INC.OAE2025-04-12
00763000995003N/AMEDTRONIC, INC.OAD2025-04-12
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAE2025-01-13
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00763000871741Sphere-9™MEDTRONIC, INC.OAE2024-11-04
00763000871802NAMEDTRONIC, INC.OAD2024-11-04
00763000871802NAMEDTRONIC, INC.OAE2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAD2024-11-04