TactiCath Contact Force Ablation Catheter
FDA premarket approval P130026/S090 · decided 2024-10-09
Approval details
- PMA number
- P130026
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TactiCath Contact Force Ablation Catheter
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2024-07-12
- Decision date
- 2024-10-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- approval of a 36-month shelf-life for the TactiFlex Ablation Catheter, Sensor Enabled and the TactiCath Contact Force Ablation Catheter, Sensor Enabled
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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 |
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| Pacel Flow Directed Pacing Catheter (K161873) | St Jude Medical | 2016-11-22 |