KAINOX RV-S/ KAINOX VCS ICD LEADS
FDA premarket approval P980023/S009 · decided 2002-11-25
Approval details
- PMA number
- P980023
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAINOX RV-S/ KAINOX VCS ICD LEADS
- Generic name
- TESTER, PACEMAKER ELECTRODE FUNCTION
- Applicant
- Biotronik, Inc.
- Date received
- 2002-06-04
- Decision date
- 2002-11-25
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- DTA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE KAINOX RV-S ACTIVE FIXATION, SINGLE SHOCK COIL ICD LEAD AND THE KAINOX VCS SINGLE SHOCK COIL ICD LEAD FOR USE AS AN ADJUNCT TO MODIFY THE SHOCK CONFIGURATION OF ICD SYSTEMS. TOGETHER WITH LEGALLY MARKETED BIOTRONIK ICDS, THESE LEAD SYSTEMS PROVIDE THE PATIENT WITH A SYSTEM THAT IS CAPABLE OF DETECTING AND TREATING VENTRICULAR TACHYARRHYTHMIAS.
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510(k) clearances by this applicant
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|---|---|---|
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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 |