PMA P980023S023
- Device
- LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S023
- Product code
- LWS
- Decision date
- 2006-07-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR A LEAD BASED ON THE KENTROX SL AND LINOX SD ICD LEADS WITH 0.11 MM FILAMENTS IN THE LEAD TIP CONDUCTOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD. CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THESE LEAD SYSTEMS WITH ICDS OF OTHER MANUFACTURERS. USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.
Current openFDA PMA Record#
- Device
- LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S023
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2006-07-11
- Decision code
- APPR
- Date received
- 2006-06-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A LEAD BASED ON THE KENTROX SL AND LINOX SD ICD LEADS WITH 0.11 MM FILAMENTS IN THE LEAD TIP CONDUCTOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD. CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THESE LEAD SYSTEMS WITH ICDS OF OTHER MANUFACTURERS. USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.