TactiCath Contact Force Ablation Catheter, Sensor Enabled
FDA premarket approval P130026/S036 · decided 2018-12-27
Approval details
- PMA number
- P130026
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2018-09-27
- Decision date
- 2018-12-27
- Days to decision
- 91 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 electrophysiological mapping and forthe treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible RFgenerator and three-dimensional mapping system.
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