FDA.reportPublic FDA data

SMARTFREEZE™

Primary DI
08714729992738
Brand
SMARTFREEZE™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004CRBS4110
Catalog number
M004CRBS4110
Device description
Inter-Connection Box
Published
2023-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
P220032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220032000POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesBoston Scientific Corporation2023-08-08OAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729992738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729992738087147299927388714729992738

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000954321NAMEDTRONIC, INC.OAE2026-04-30
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-20
00763000993269Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-08
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