LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
FDA premarket approval P980023/S027 · decided 2007-01-26
Approval details
- PMA number
- P980023
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 2006-12-18
- Decision date
- 2007-01-26
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR LEADS BASED ON THE LINOX SD AND LINOX TD LEADS WITH ONE SHOCK COIL INSTEAD OF TWO SHOCK COILS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES LINOX S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD AND LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD AND ARE 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 SENS
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510(k) clearances by this applicant
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