FDA.reportPublic FDA data

Blazer Prime® XP

Primary DI
08714729802327
Brand
Blazer Prime® XP
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004P4500TH0
Catalog number
M004P4500TH0
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
OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020025020
P020025021
P020025026
P020025028
P020025029
P020025031
P020025044
P020025049
P020025059
P020025060
P020025061
P020025067
P020025088
P020025101
P020025120
P020025127
P020025129
P020025141
P020025146

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020025020EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025021EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025026EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025028EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025029EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025031EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025044EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025049EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025059EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025060EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025061EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025067EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025088EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025101EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025120EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025127EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025129EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025141EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025146EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729802327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729802327087147298023278714729802327

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
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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
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAD2025-01-14
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
00191506020798RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONOAD2024-09-03
00191506020804RHYTHMIA HDx™BOSTON SCIENTIFIC CORPORATIONOAD2024-09-03
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04260166373103INTELLAGEN™ Serial Communication Cable (5m)Stockert GmbHOAD2024-09-01
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04260166373127INTELLAGEN™ Remote Control Connection Cable (25m)Stockert GmbHOAD2024-09-01
04260166373134INTELLAGEN™ Irrigation Pump Connection Cable (5m)Stockert GmbHOAD2024-09-01
04260166373158INTELLAGEN™ Catheter Adapter Cable (0.3m)Stockert GmbHOAD2024-09-01