Sphere-9 Mapping and Ablation Catheter, Tubing Set
FDA premarket approval P240013/S004 · decided 2024-12-23
Approval details
- PMA number
- P240013
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sphere-9 Mapping and Ablation Catheter, Tubing Set
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Medtronic, Inc.
- Date received
- 2024-12-03
- Decision date
- 2024-12-23
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- a change in Bacterial Endotoxin Testing (BET) for the Sphere-9 Catheter and Tubing Set, Ethylene Oxide (EO) sterilized atProfessional Contract Sterilization (PCS) in Taunton, Massachusetts and Sterigenics in Queensbury, New York
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510(k) clearances by this applicant
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|---|---|---|
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| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |