RELIATY/MODEL 3145 PACING SYSTEM ANALYZER
FDA premarket approval P950037/S079 · decided 2010-09-02
Approval details
- PMA number
- P950037
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIATY/MODEL 3145 PACING SYSTEM ANALYZER
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2010-03-23
- Decision date
- 2010-09-02
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A STAND-ALONE VERSION OF THE PACING SYSTEM ANALYZER FUNCTION FOUND IN THE ICS 3000 IMPLANT CONTROL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RELIATY BY BIOTRONIK, INC. AND MODEL 3145 BY BOSTON SCIENTIFIC AND IS INDICATED FOR USE IN PACING LEAD SYSTEM ANALYSIS DURING THE IMPLANTATION OF PACEMAKERS AND DEFIBRILLATORS.
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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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| 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 |