SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53
FDA premarket approval P950037/S038 · decided 2004-11-10
Approval details
- PMA number
- P950037
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Biotronik, Inc.
- Date received
- 2004-05-27
- Decision date
- 2004-11-10
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX ST/JT AND IS INDICATED AS FOLLOWS: SELOX ST AND SELOX JT STEROID ELUTING LEADS ARE DESIGNED FOR USE WITH IMPLANTABLE PULSE GENERATORS THAT REQUIRE PACING LEADS WITH A BIPOLAR 3.2 MM IS-1 CONNECTOR CONFIGURATION; THEY MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS. THE LEADS ARE DESIGNED FOR USE IN PATIENTS FOR WHOM SINGLE OR DUAL CHAMBER PULSE GENERATOR THER
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