KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
FDA premarket approval P980023/S018 · decided 2004-07-27
Approval details
- PMA number
- P980023
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KENTROX RV STEROID AND KENTROX SL STEROID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 2004-06-14
- Decision date
- 2004-07-27
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR ADDITION OF THE STEROID COLLAR TO THE DISTAL END OF THE LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME KENTROX SL STEROID AND KENTROX RV STEROID AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.
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