FDA.reportPublic FDA data

Blazer® II HTD

Primary DI
08714729333326
Brand
Blazer® II HTD
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0045086THK20
Catalog number
M0045086THK20
Device description
Temperature Ablation Catheter
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPBCardiac ablation percutaneous catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPBCardiac Ablation Percutaneous CatheterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920047000
P920047001
P920047002
P920047003
P920047004
P920047006
P920047007
P920047008
P920047009
P920047010
P920047012
P920047015
P920047017
P920047018
P920047019
P920047021
P920047023
P920047024
P920047026
P920047027
P920047028
P920047030
P920047031
P920047035
P920047036
P920047037
P920047039
P920047040
P920047045
P920047047
P920047048
P920047049
P920047060
P920047063
P920047071
P920047072
P920047073
P920047076
P920047080
P920047092
P920047098
P920047116
P920047124
P920047133
P920047137

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920047000EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047001EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047002EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047003EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047004EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047006EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047007EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047008EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047009EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047010EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047012EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047015EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047017EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047018EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047019EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047021EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047023EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047024EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047026EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047027EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047028EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047030EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047031EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047035EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047036EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047037EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047039EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047040EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047045EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047047EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047048EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047049EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047060EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047063EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047071EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047072EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047073EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047076EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047080EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047092EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047098EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047116EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047124EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047133EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB
P920047137EPT-1000 CARDIAC ABLATION SYSTEMBoston Scientific Corp1994-10-28LPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729333326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729333326087147293333268714729333326

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac radio-frequency ablation system catheterA sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00763000911089NAMEDTRONIC, INC.LPB2025-02-21
05415067046734Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.LPB2025-01-14
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONLPB2024-09-03
04260166373066INTELLAGEN™ Foot PedalStockert GmbHLPB2024-09-01
04260166373097INTELLAGEN™ ECG Connection Cable (3m)Stockert GmbHLPB2024-09-01
04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHLPB2024-09-01
04260166373110INTELLAGEN™ Serial Communication Cable (15m)Stockert GmbHLPB2024-09-01
04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHLPB2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHLPB2024-09-01
04260166373219INTELLAGEN™ Remote Control Connection Cable (10m)Stockert GmbHLPB2024-09-01
04260166373226INTELLAGEN™ Remote Control Connection Cable (15m)Stockert GmbHLPB2024-09-01
04260166373233INTELLAGEN™ Remote Control Connection Cable (30m)Stockert GmbHLPB2024-09-01
04260166373271INTELLAGEN™ Foot Pedal Extension Cable (7m)Stockert GmbHLPB2024-09-01
04260166373288INTELLAGEN™ Serial Communication Cable (3m)Stockert GmbHLPB2024-09-01
04260166374063INTELLAGEN™ RF GeneratorStockert GmbHLPB2024-09-01
04260166374070INTELLAGEN™ RF Generator KitStockert GmbHLPB2024-09-01
04260166374094INTELLAGEN™ Remote Control KitStockert GmbHLPB2024-09-01
04260166374100INTELLAGEN™ Remote ControlStockert GmbHLPB2024-09-01
04260166374117INTELLAGEN™ Irrigation PumpStockert GmbHLPB2024-09-01
00763000719265NAMEDTRONIC, INC.LPB2024-08-22
00763000719319NAMEDTRONIC, INC.LPB2024-08-22
00763000593889NAMEDTRONIC, INC.LPB2024-02-17