KENTROX RV LEAD SYSTEMS
FDA premarket approval P980023/S007 · decided 2002-02-21
Approval details
- PMA number
- P980023
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- KENTROX RV LEAD SYSTEMS
- Generic name
- TESTER, PACEMAKER ELECTRODE FUNCTION
- Applicant
- Biotronik, Inc.
- Date received
- 2002-01-22
- Decision date
- 2002-02-21
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- DTA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A NAME CHANGE FOR THE TEROX RV 65 AND TEROX RV 75 LEADS. THE DEVICE WILL NOW BE MARKETED UNDER THE TRADE NAME KENTROX RV 65 (MODEL 332 232) AND KENTROX RV 75 (MODEL 332 231) AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).
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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 |