FDA.reportPublic FDA data

SMARTFREEZE™

Primary DI
08714729992721
Brand
SMARTFREEZE™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M004CRBS400R0
Catalog number
M004CRBS400R0
Device description
Cryo-Console
Published
2023-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08714729992721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729992721087147299927218714729992721

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac cryosurgical systemA mobile assembly of mains electricity (AC-powered) devices intended to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It typically includes a console, monitor, connection cable(s), electrocardiogram (ECG) electrodes, and a cryoablation catheter in which extremely low temperatures are achieved through expansion of a pressurized liquid refrigerant (e.g., nitrous oxide) at the catheter tip; monitoring is achieved via ECG displays and sensors within the catheter.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150003709Sphere-9™ CatheterMEDTRONIC, INC.OAE2026-02-20
00763000998332HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2025-08-30
20763000954363N/AMEDTRONIC, INC.OAE2025-02-22
05415067046734Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
05415067046741Ampere™ST. JUDE MEDICAL, INC.OAE2025-01-14
00763000708917DiamondTemp™ FASTR RF GeneratorMEDTRONIC, INC.OAE2024-12-14
00763000709051DiamondTemp™ Irrigation PumpMEDTRONIC, INC.OAE2024-12-13
00763000973391Sphere-9™ CatheterMEDTRONIC, INC.OAE2024-12-06
00763000871895HexaFlow™ Irrigation PumpMEDTRONIC, INC.OAE2024-11-04
00763000871925HexaPulse™ PF GeneratorMEDTRONIC, INC.OAE2024-11-04
00763000228699NAMEDTRONIC, INC.OAE2024-06-28
08714729992233INTELLANAV STABLEPOINT™BOSTON SCIENTIFIC CORPORATIONOAE2024-02-29
08714729992240INTELLANAV STABLEPOINT™BOSTON SCIENTIFIC CORPORATIONOAE2024-02-29
00763000709136DiamondTemp™ Catheter-to-RFG CableMEDTRONIC, INC.OAE2024-01-12
00763000709150DiamondTemp™ Genconnect CableMEDTRONIC, INC.OAE2024-01-12
00763000536671DiamondTemp™ Bidirectional Ablation CatheterMEDTRONIC, INC.OAE2023-12-30
00763000536688DiamondTemp™ Bidirectional Ablation CatheterMEDTRONIC, INC.OAE2023-12-30
00763000709198DiamondTemp™ Foot SwitchMEDTRONIC, INC.OAE2023-12-16
00763000709181DiamondTemp™ Irrigation Tubing SetMEDTRONIC, INC.OAE2023-11-26
00763000709174DiamondTemp™ Irrigation Tubing SetMEDTRONIC, INC.OAE2023-11-26
00840216123014ASP MEDICALAsp Global, LLCOAE2023-10-19
08714729992752SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-09-29
08714729992714SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-09-25
08714729997481SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-09-25
00191506007737SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
00191506015701SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
00191506016463POLARx™ FITBOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
00191506039677SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
00191506039684SMARTFREEZE™BOSTON SCIENTIFIC CORPORATIONOAE2023-08-21
08714729992615POLARx™BOSTON SCIENTIFIC CORPORATIONOAE2023-08-21