SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60)
FDA premarket approval P950037/S042 · decided 2006-02-14
Approval details
- PMA number
- P950037
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60)
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Biotronik, Inc.
- Date received
- 2005-11-09
- Decision date
- 2006-02-14
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SELOX SR PACING LEAD FAMILY TO CHANGE THE STEROID DOSAGE, MAXIMUM LEAD BODY DIAMETER, AND RING ELECTRODE BASE MATERIAL, AS WELL AS OTHER MINOR CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD AND IS INDICATED FOR PERMANENT PACING AND SENSING.
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510(k) clearances by this applicant
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