DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137
FDA premarket approval P950037/S048 · decided 2007-03-08
Approval details
- PMA number
- P950037
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2006-12-13
- Decision date
- 2007-03-08
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR AN ADDITIONAL TRADE NAME FOR THE MARKET APPROVED SETROX S LEAD, AS WELL AS MINOR CHANGES TO THE ACCESSORIES, PACKAGING, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXTRUS, AND LABELED FOR DISTRIBUTION BY GUIDANT. THE DEXTRUS LEAD IS INDICATED FOR PERMANENT PACING AND SENSING IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS.
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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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| 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 |