STRATOS LV/LV-T
FDA premarket approval P070008/S019 · decided 2011-04-15
Approval details
- PMA number
- P070008
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STRATOS LV/LV-T
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- Date received
- 2010-10-28
- Decision date
- 2011-04-15
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1004.U.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |