CONFIENT SW AND LIVIAN SW
FDA premarket approval P960040/S175 · decided 2009-08-18
Approval details
- PMA number
- P960040
- Supplement
- S175
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONFIENT SW AND LIVIAN SW
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-08-15
- Decision date
- 2009-08-18
- Days to decision
- 368 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE PROGRAMMER SW MODEL 2888 V1.08 AND PROGRAMMER MODEL 2945 V1.02.
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