TactiCath Contact Force Ablation Catheter, Sensor Enabled
FDA premarket approval P130026/S064 · decided 2020-08-25
Approval details
- PMA number
- P130026
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2020-08-03
- Decision date
- 2020-08-25
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Modification of proximal cable leakage current in-process controls for the TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE).
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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 |