Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set
FDA premarket approval P240013/S001 · decided 2024-11-22
Approval details
- PMA number
- P240013
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Medtronic, Inc.
- Date received
- 2024-10-24
- Decision date
- 2024-11-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- the addition of an alternate sterilization Cycle 424 at a currently contract sterilizer facility, Sterigenics US LLC, Queensbury, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
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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 |