SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
FDA premarket approval P950037/S034 · decided 2004-03-08
Approval details
- PMA number
- P950037
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
- Generic name
- permanent pacemaker Electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2003-07-14
- Decision date
- 2004-03-08
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX SR AND IS INDICATED AS FOLLOWING: BOTRONIK'S SELOX SR TRANSVENOUS, STEROID-ELUTING, ACTIVE FIXATION ENDOCARDIAL LEADS ARE INDICATED FOR PERMANENT PACING AND SENSING. ACTIVE FIXATION PACING LEADS WITH A BIPOLAR (BP) IS-1 CONNECTOR CONFIGURATION ARE DESIGNED FOR USE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS. THE LEADS MAY BE USED WITH SINGLE OR DU
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510(k) clearances by this applicant
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| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
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