VARIOUS MODELS OF ICD'S
FDA premarket approval P000009/S019 · decided 2006-07-26
Approval details
- PMA number
- P000009
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS MODELS OF ICD'S
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- Biotronik, Inc.
- Date received
- 2006-06-29
- Decision date
- 2006-07-26
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR PROGRAMMER SOFTWARE MODIFICATIONS (601.U AND A-K00.8.U) FOR USE IN BIOTRONIK PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. THE MODIFICATIONS INCLUDED ADDING THE 1-OPT FEATURE, EXPANDING PROGRAMMER CAPABILITIES, IMPROVING PRINTING AND DATA IMPORT/EXPORT CAPABILITIES, ENHANCING COMMUNICATION AND MEMORY, UPDATING PROGRAMMABILITY AND RAM AND CORRECTING SOFTWARE ANOMALIES. THE SOFTWARE IS FOR USE WITH EPR 1000 PLUS PROGRAMMING SYSTEM, TMS 1000 PLUS PROGRAMMING SYSTEM AND ICS 30
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
| Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (K250706) | Biotronik, Inc. | 2025-04-04 |
| 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 |