TactiCath Quartz Contact Force Ablation Catheter
FDA premarket approval P130026/S058 · decided 2020-06-05
Approval details
- PMA number
- P130026
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TactiCath Quartz Contact Force Ablation Catheter
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2020-03-11
- Decision date
- 2020-06-05
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for modification to the counterbore depth specification.
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