LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
FDA premarket approval P010012/S154 · decided 2008-02-15
Approval details
- PMA number
- P010012
- Supplement
- S154
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2007-08-22
- Decision date
- 2008-02-15
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LIVIAN CRT-D DEVICES WITH CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2945, VERSION 1.01.
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