POLARx™
- Primary DI
- 08714729992677
- Brand
- POLARx™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M004CRBS2150
- Catalog number
- M004CRBS2150
- Device description
- Cryoablation Balloon Catheter
- Published
- 2023-08-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P220032 | 000 | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | Boston Scientific Corporation | 2023-08-08 | OAE |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729992677 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729992677 | 08714729992677 | 8714729992677 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac cryosurgical system catheter | A 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 |
|---|
| Outer Diameter | 4 | Millimeter |
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
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 00763000708917 | DiamondTemp™ FASTR RF Generator | MEDTRONIC, INC. | OAE | 2024-12-14 |
| 00763000709051 | DiamondTemp™ Irrigation Pump | MEDTRONIC, INC. | OAE | 2024-12-13 |
| 00763000973391 | Sphere-9™ Catheter | MEDTRONIC, INC. | OAE | 2024-12-06 |
| 00763000871895 | HexaFlow™ Irrigation Pump | MEDTRONIC, INC. | OAE | 2024-11-04 |
| 00763000871925 | HexaPulse™ PF Generator | MEDTRONIC, INC. | OAE | 2024-11-04 |
| 00763000228699 | NA | MEDTRONIC, INC. | OAE | 2024-06-28 |
| 08714729992233 | INTELLANAV STABLEPOINT™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2024-02-29 |
| 08714729992240 | INTELLANAV STABLEPOINT™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2024-02-29 |
| 00763000709136 | DiamondTemp™ Catheter-to-RFG Cable | MEDTRONIC, INC. | OAE | 2024-01-12 |
| 00763000709150 | DiamondTemp™ Genconnect Cable | MEDTRONIC, INC. | OAE | 2024-01-12 |
| 00763000536671 | DiamondTemp™ Bidirectional Ablation Catheter | MEDTRONIC, INC. | OAE | 2023-12-30 |
| 00763000536688 | DiamondTemp™ Bidirectional Ablation Catheter | MEDTRONIC, INC. | OAE | 2023-12-30 |
| 00763000709198 | DiamondTemp™ Foot Switch | MEDTRONIC, INC. | OAE | 2023-12-16 |
| 00763000709181 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | OAE | 2023-11-26 |
| 00763000709174 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | OAE | 2023-11-26 |
| 00840216123014 | ASP MEDICAL | Asp Global, LLC | OAE | 2023-10-19 |
| 08714729992752 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-29 |
| 08714729992714 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-25 |
| 08714729992721 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-25 |
| 08714729997481 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-25 |
| 00191506007737 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506015701 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506016463 | POLARx™ FIT | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506039677 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506039684 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |