Product code OAE
- Device name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For the treatment of atrial fibrillation.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P220013S029 | TactiFlex™ Ablation Catheter, Sensor Enabled™ (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF; A-TFSE-FJ; | ABBOTT MEDICAL | 2026-05-15 |
| P130026S099 | TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- | St Jude Medical | 2026-05-15 |
| P100010S153 | Freezor MAX 209F3,209F5 | Medtronic Cryocath, LP | 2026-04-23 |
| P210027S016 | QDOT MICRO™ System | Biosense Webster, Inc. | 2026-04-17 |
| P220013S027 | TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T | ABBOTT MEDICAL | 2026-02-03 |
| P220013S026 | TactiFlex™ Sensor Enabled™ | ABBOTT MEDICAL | 2026-01-15 |
| P130026S098 | TactiCath™ Sensor Enabled™ | St Jude Medical | 2026-01-15 |
| P220013S025 | TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) | ABBOTT MEDICAL | 2026-01-08 |
| P130026S097 | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) | St Jude Medical | 2026-01-08 |
| P130026S096 | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | St Jude Medical | 2025-12-23 |
| P220013S023 | TactiFlex™ Ablation Catheter, Sensor Enabled ™ (TactiFlex SE) | ABBOTT MEDICAL | 2025-10-30 |
| P200028S026 | DiamondTemp Ablation System | Medtronic, Inc. | 2025-10-10 |
| P220032S011 | POLARx™ Cryoablation System | Boston Scientific Corporation | 2025-08-14 |
| P220013S021 | TactiFlex™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-08-07 |
| P220013S020 | TactiFlex™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-08-01 |
| P220013S019 | TactiFlex Ablation Catheter, Sensor Enabled | ABBOTT MEDICAL | 2025-06-20 |
| P130026S094 | TactiCath Contact Force Ablation Catheter, Sensor Enabled | St Jude Medical | 2025-06-20 |
| P130026S095 | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | St Jude Medical | 2025-05-06 |
| P220013S018 | TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) | ABBOTT MEDICAL | 2025-04-11 |
| P220013S017 | TactiFlex™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-04-10 |
| P130026S093 | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | St Jude Medical | 2025-04-10 |
| P210027S012 | QDOT MICRO™ System | Biosense Webster, Inc. | 2025-04-08 |
| P100010S150 | ARCTIC FRONT CRYOCATHETER SYSTEM | Medtronic Cryocath, LP | 2025-03-27 |
| P220032S010 | Boston Scientific Cardiac Cryoablation System | Boston Scientific Corporation | 2025-03-21 |
| P100010S151 | ARCTIC FRONT CRYOCATHETER SYSTEM | Medtronic Cryocath, LP | 2025-03-18 |
| P220013S011 | TactiFlex™ Ablation Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2025-03-05 |
| P210027S014 | TX eco EXT Cable | Biosense Webster, Inc. | 2025-02-26 |
| P210027S015 | QDOT MICRO System | Biosense Webster, Inc. | 2025-02-25 |
| P220032S009 | SMARTFREEZE™ Cryo-Cable | Boston Scientific Corporation | 2025-02-10 |
| P220013S015 | TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) | ABBOTT MEDICAL | 2024-11-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000954321 | NA | MEDTRONIC, INC. | 2026-04-30 |
| 00763000993269 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2026-02-08 |
| 00763000998363 | HexaPulse™ PF Generator | MEDTRONIC, INC. | 2025-08-30 |
| 00763000998301 | HexaGen™ RF Generator | MEDTRONIC, INC. | 2025-08-30 |
| 00763000995003 | N/A | MEDTRONIC, INC. | 2025-04-12 |
| 00763000973506 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2025-01-13 |
| 00763000871741 | Sphere-9™ | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871772 | NA | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871802 | NA | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871864 | HexaGen™ RF Generator | MEDTRONIC, INC. | 2024-11-04 |
| 00191506034429 | RHYTHMIA HDx™ | BOSTON SCIENTIFIC CORPORATION | 2024-03-02 |
| 00191506020408 | IntellaNav StablePoint™ Cable | BOSTON SCIENTIFIC CORPORATION | 2024-02-29 |
| 20763000709185 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | 2023-11-26 |
| 00763000687984 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | 2023-08-03 |
| 10846835016734 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835017045 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835016758 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835016741 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 10846835016727 | QDOT MICRO | Biosense Webster Inc | 2023-07-07 |
| 00763000482169 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | 2021-10-21 |
| 00763000245481 | Freezor® MAX | MEDTRONIC, INC. | 2020-12-25 |
| 05415067013378 | Ampere™ | ST. JUDE MEDICAL, INC. | 2020-11-27 |
| 00859373007433 | HeartLight | CARDIOFOCUS, INC. | 2020-05-19 |
| 00859373007440 | HeartLight | CARDIOFOCUS, INC. | 2020-05-19 |
| 00859373007464 | HeartLight | CARDIOFOCUS, INC. | 2020-05-19 |
| 00859373007495 | HeartLight | CARDIOFOCUS, INC. | 2020-05-19 |
| 05415067004901 | Ampere™ | ST. JUDE MEDICAL, INC. | 2015-02-05 |
| 05415067004888 | Ampere™ | ST. JUDE MEDICAL, INC. | 2014-12-03 |
| 05415067004925 | Ampere™ | ST. JUDE MEDICAL, INC. | 2014-12-03 |
| 05415067004949 | Ampere™ | ST. JUDE MEDICAL, INC. | 2014-12-03 |