FDA.reportPublic FDA data

Blazer Prime® HTD

Primary DI
08714729803591
Brand
Blazer Prime® HTD
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004P5031THK20
Catalog number
M004P5031THK20
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
P920047039
P920047040
P920047045
P920047047
P920047048
P920047049
P920047060
P920047063
P920047071
P920047072
P920047073
P920047076
P920047092
P920047098
P920047116
P920047123
P920047124
P920047133
P920047137

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
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
P920047123EPT-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
08714729803591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729803591087147298035918714729803591

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
00191506049232Orbera™M00505670M005056702026-06-04
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

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