TactiCath Contact Force Ablation Catheter, Sensor Enabled
FDA premarket approval P130026/S070 · decided 2021-11-04
Approval details
- PMA number
- P130026
- Supplement
- S070
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TactiCath Contact Force Ablation Catheter, Sensor Enabled
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2021-04-01
- Decision date
- 2021-11-04
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for the TactiCath Contact Force Ablation Catheter, Sensor Enabled. The device is indicated for use in cardiac electrophysiology mapping and for the treatment of drug refractory recurrent symptomatic, paroxysmal, and persistent atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
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|---|---|---|
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| Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (K160335) | St Jude Medical | 2016-12-13 |
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| AutoMark Module (K160218) | St Jude Medical | 2016-12-13 |
| EnSite Precision Cardiac Mapping System v2.0 (K160210) | St Jude Medical | 2016-12-13 |
| Pacel Flow Directed Pacing Catheter (K161873) | St Jude Medical | 2016-11-22 |