LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD
FDA premarket approval P980023/S037 · decided 2009-01-05
Approval details
- PMA number
- P980023
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LINOX SD 60/16 STEROID-ELUTING, ACTIVE FIXATION ICD LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 2008-11-20
- Decision date
- 2009-01-05
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE ADDITION OF A 61.2 CM LEAD IN ADDITION TO THE PREVIOUSLY APPROVED 65 AND 75 CM LEADS.
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510(k) clearances by this applicant
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