Product code LPB
- Device name
- Cardiac Ablation Percutaneous Catheter
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P020045S113 | Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5 | Medtronic Cryocath, LP | 2026-04-23 |
| P960016S093 | Livewire™ TC XLS™ | St Jude Medical | 2026-01-15 |
| P240014 | MAGiC Ablation Catheter | Stereotaxis, Inc. | 2026-01-05 |
| P990071S068 | nGEN™ Pump | Biosense Webster, Inc. | 2025-12-23 |
| P920047S138 | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (M004RA65010) | Boston Scientific Corp | 2025-10-17 |
| P990071S067 | SMARTABLATE™ System Interface Cable (D-1303-02-S) | Biosense Webster, Inc. | 2025-09-15 |
| P920047S137 | Blazer™ II Cardiac Ablation System and Cable | Boston Scientific Corp | 2025-08-14 |
| P960016S092 | Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable | St Jude Medical | 2025-04-10 |
| P040014S050 | Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables | Irvine Biomedical, Inc. | 2025-04-10 |
| P920047S136 | RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) | Boston Scientific Corp | 2025-03-31 |
| P990071S066 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | Biosense Webster, Inc. | 2025-03-28 |
| P020045S112 | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM | Medtronic Cryocath, LP | 2025-03-27 |
| P920047S135 | IntellaNav ST Ablation Catheter | Boston Scientific Corp | 2025-03-20 |
| P990071S065 | SmartAblate System Interface Cable | Biosense Webster, Inc. | 2025-02-26 |
| P950005S088 | Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) | Biosense Webster, Inc. | 2025-02-26 |
| P040036S100 | Thermocool Deflectable Diagnostic/ Ablation Catheter | Biosense Webster, Inc. | 2025-02-25 |
| P990071S063 | SMARTABLATE™ Irrigation Tubing Set | Biosense Webster, Inc. | 2025-02-11 |
| P990071S064 | nGEN™ Pump | Biosense Webster, Inc. | 2025-01-22 |
| P020045S110 | Nitron CryoConsole, Nitron Foot Switch | Medtronic Cryocath, LP | 2024-11-25 |
| P990071S062 | Theermocool SF NAV Bi-Directional Catheter | Biosense Webster, Inc. | 2024-11-20 |
| P040036S099 | Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter | Biosense Webster, Inc. | 2024-11-20 |
| P990071S060 | Smartablate System Interface Cable | Biosense Webster, Inc. | 2024-11-15 |
| P950005S087 | nMARQ Catheter Interference Cable | Biosense Webster, Inc. | 2024-11-15 |
| P040036S097 | nMARQ Catheter Interference Cable | Biosense Webster, Inc. | 2024-11-15 |
| P020045S111 | Coaxial Umbilical Cable | Medtronic Cryocath, LP | 2024-11-13 |
| P990071S061 | nGEN™ Pump | Biosense Webster, Inc. | 2024-10-30 |
| P040014S049 | Therapy™ Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19- | Irvine Biomedical, Inc. | 2024-10-15 |
| P920047S133 | INTELLAGEN™ Cardiac Ablation System | Boston Scientific Corp | 2024-07-17 |
| P930029S072 | RF Catheter Cables | Medtronic, Inc. | 2024-07-01 |
| P040036S098 | THERMOCOOL SMARTTOUCH SF Catheter | Biosense Webster, Inc. | 2024-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00191506020804 | RHYTHMIA HDx™ | BOSTON SCIENTIFIC CORPORATION | 2024-09-03 |
| 00763000412579 | N/A | MEDTRONIC, INC. | 2023-02-25 |
| 20763000359366 | NA | MEDTRONIC, INC. | 2023-02-25 |
| 00763000542115 | Freezor™ Xtra | MEDTRONIC, INC. | 2022-04-11 |
| 00763000542108 | Freezor™ Xtra | MEDTRONIC, INC. | 2022-04-11 |
| 00763000542092 | Freezor™ Xtra | MEDTRONIC, INC. | 2022-04-11 |
| 00763000245474 | Freezor® MAX | MEDTRONIC, INC. | 2020-12-24 |
| 00763000228682 | N/A | MEDTRONIC, INC. | 2020-04-27 |
| 08714729861997 | Maestro 4000™ Pod, 100W | BOSTON SCIENTIFIC CORPORATION | 2017-11-06 |
| 00643169950153 | NA | MEDTRONIC, INC. | 2017-04-02 |
| 08714729756811 | Maestro™ Remote Control Cable -25' | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729790006 | Maestro 3000™ Remote Control Panel | BOSTON SCIENTIFIC CORPORATION | 2015-10-14 |
| 08714729821755 | Maestro 3000® RF Cardiac Ablation Pod 100 | BOSTON SCIENTIFIC CORPORATION | 2015-10-14 |
| 00643169504905 | Freezor® MAX | MEDTRONIC, INC. | 2015-09-18 |
| 00643169504899 | Freezor® MAX | MEDTRONIC, INC. | 2015-09-18 |
| 08714729861942 | Maestro 4000™ Controller | BOSTON SCIENTIFIC CORPORATION | 2015-01-27 |
| 08714729861980 | Maestro 4000™ Pod, 100W | BOSTON SCIENTIFIC CORPORATION | 2015-01-27 |
| 08714729862062 | Maestro 4000™ Remote Control | BOSTON SCIENTIFIC CORPORATION | 2015-01-27 |
| 08714729862093 | Maestro 4000™ Remote Control | BOSTON SCIENTIFIC CORPORATION | 2015-01-27 |
| 00643169450370 | Freezor® MAX | MEDTRONIC, INC. | 2014-12-01 |
| 00643169450387 | Freezor® MAX | MEDTRONIC, INC. | 2014-12-01 |
| 08714729811923 | Maestro 3000™ | BOSTON SCIENTIFIC CORPORATION | 2014-11-11 |
| 00643169023482 | Freezor® MAX | MEDTRONIC, INC. | 2014-09-23 |
| 10681490023877 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169023475 | Freezor® MAX | MEDTRONIC, INC. | 2014-09-23 |
| 00643169023345 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169023307 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00613994804273 | Freezor® MAX | MEDTRONIC, INC. | 2014-09-23 |
| 00613994775986 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00613994775566 | NA | MEDTRONIC, INC. | 2014-09-23 |