Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec
FDA premarket approval P950037/S165 · decided 2016-07-26
Approval details
- PMA number
- P950037
- Supplement
- S165
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Biotronik, Inc.
- Date received
- 2016-06-09
- Decision date
- 2016-07-26
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for the addition of the Siello S and Solia S leads to the ProMRI CRT-D system.
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510(k) clearances by this applicant
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|---|---|---|
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
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| 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 |