KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
FDA premarket approval P980023/S017 · decided 2004-09-30
Approval details
- PMA number
- P980023
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KENTROX RV-S STEROID AND KENTROX SL-2 STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 2004-04-02
- Decision date
- 2004-09-30
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR ADDITION OF A STEROID COLLAR TO SINGLE COIL AND DUAL COIL LEAD VERSIONS, AND MODIFICATIONS TO THE CONDUCTOR COIL AND FIXATION HELIX.
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510(k) clearances by this applicant
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| 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 |