ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.
FDA premarket approval P930029/S048 · decided 2015-03-05
Approval details
- PMA number
- P930029
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic, Inc.
- Date received
- 2014-12-23
- Decision date
- 2015-03-05
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGES TO LABELING AND PACKAGING FOR SPECIFIC ACCESSORIES (I.E., CABLES AND FOOT SWITCH) USED WITH THE MEDTRONIC ATAKR RFCA SYSTEMS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| 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 |