STRATOS LV-T
FDA premarket approval P070008/S003 · decided 2008-06-24
Approval details
- PMA number
- P070008
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STRATOS LV-T
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- Date received
- 2008-06-02
- Decision date
- 2008-06-24
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A DIODE CHANGE IN THE STRATOS LV AND LV-T CRT-PS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STRATOS LV CRT-P AND STRATOS LV-T CRT-P AND IS INDICATED FOR TREATMENT OF BRADYCARDIA IN HEART FAILURE PATIENTS.
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510(k) clearances by this applicant
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