TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE)
FDA premarket approval P220013/S010 · decided 2023-10-24
Approval details
- PMA number
- P220013
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE)
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-09-29
- Decision date
- 2023-10-24
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- a change to the manufacturing process to consolidate the number of adhesives used in the manufacture of the TactiFlex Ablation Catheter, Sensor Enabled
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510(k) clearances by this applicant
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|---|---|---|
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |