FDA.reportPublic FDA data

IntellaTip MiFi™ Filter Module

Primary DI
08714729854395
Brand
IntellaTip MiFi™ Filter Module
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0041212H0
Device description
RF Frequency Filter
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P020025036
P020025045
P020025046
P020025059
P020025060
P020025061
P020025074
P020025075

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020025036EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025045EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025046EP 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
P020025074EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD
P020025075EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMBoston Scientific2003-08-25OAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729854395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729854395087147298543958714729854395

GMDN Terms#

Term, Definition table
TermDefinition
Electronic signal frequency filterAn electronic filter that transfers electronic signals at all frequencies within a certain area, and suppresses signals at all other frequencies outside this area. This GMDN code also includes octave and third-octave filters.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506041656FARASTAR™M004PF41M434M004PF41M4342024-02-14
00191506041663FARASTAR™M004PF41M444M004PF41M4442024-02-09
08714729796695Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200002014-09-24
08714729802822Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200R02014-09-24
08714729961154Alair Bronchial Thermoplasty RF ControllerATS 200M005ATS200RR02017-08-07
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954345NAMEDTRONIC, INC.OAD2026-08-14
10846835026726Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterBiosense Webster IncOAD2026-07-09
00763000954321NAMEDTRONIC, INC.OAD2026-04-30
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
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