XELOS DR-T ICD'S
FDA premarket approval P000009/S057 · decided 2014-05-04
Approval details
- PMA number
- P000009
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- XELOS DR-T ICD'S
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Biotronik, Inc.
- Date received
- 2013-11-25
- Decision date
- 2014-05-04
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR MRI-CONDITIONAL LABELING FOR THE ENTOVIS SR / SR-T / DR / DR-T PACEMAKERS, AND THE SUPPORTING PROGRAMMER SOFTWARE VERSION PSW 1307.U. WHEN AN ENTOVIS PACEMAKER IS USED IN CONJUNCTION WITH SETROX S 53/60 OR SAFIO 53/60 PACEMAKER LEADS IT SHALL BEIDENTIFIED AS THE ENTOVIS PROMRI SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
| Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (K250706) | Biotronik, Inc. | 2025-04-04 |
| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
| Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787) | Biotronik, Inc. | 2024-09-12 |
| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |