FDA.reportPublic FDA data

Arctic Front Advance™

Primary DI
00643169753693
Brand
Arctic Front Advance™
Company
MEDTRONIC, INC.
Model
2AF284
Device description
CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
Published
2016-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100010015
P100010054

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100010015ARCTIC FRONT CRYOCATHETER SYSTEMMedtronic Cryocath, LP2010-12-17OAE
P100010054ARCTIC FRONT CRYOCATHETER SYSTEMMedtronic Cryocath, LP2010-12-17OAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169753693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169753693006431697536936431697536930643169753693

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac cryosurgical system catheterA sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length95Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-31 Degrees Fahrenheit113 Degrees Fahrenheit
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

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Primary DI, Brand, Company table
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05415067051943N/AST. JUDE MEDICAL, INC.OAE2025-10-31
05415067051950TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067051998TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052018TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052025TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052056TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052063TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052216TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
05415067052223TactiFlex™ Sensor Enabled™ST. JUDE MEDICAL, INC.OAE2025-10-29
00763000998301HexaGen™ RF GeneratorMEDTRONIC, INC.OAE2025-08-30
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2025-08-30
00763000998363HexaPulse™ PF GeneratorMEDTRONIC, INC.OAE2025-08-30
00763000995003N/AMEDTRONIC, INC.OAE2025-04-12
20763000954363N/AMEDTRONIC, INC.OAE2025-02-22
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046789Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
00763000973506Sphere-9™ CatheterMEDTRONIC, INC.OAE2025-01-13
00763000708917DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.OAE2024-12-14
00763000709051DiamondTemp™ Irrigation PumpMEDTRONIC, INC.OAE2024-12-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAE2024-12-06
00763000871772NAMEDTRONIC, INC.OAE2024-11-04
00763000871741Sphere-9™MEDTRONIC, INC.OAE2024-11-04
00763000871802NAMEDTRONIC, INC.OAE2024-11-04
00763000871864HexaGen™ RF GeneratorMEDTRONIC, INC.OAE2024-11-04
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAE2024-11-04