PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE
FDA premarket approval P950037/S012 · decided 2000-06-22
Approval details
- PMA number
- P950037
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE
- Generic name
- permanent pacemaker Electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2000-05-15
- Decision date
- 2000-06-22
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE PHILOS PULSE GENERATOR FAMILY AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHILOS DR, PHILOS DR-B, PHILOS D, PHILOS SR, PHILOS SR-B, PHILOS S, PHILOS SLR, AND THE SWM1000 B-K00.0.U SOFTWARE CARTRIDGE.
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510(k) clearances by this applicant
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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 |