LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229
FDA premarket approval P010012/S176 · decided 2008-04-17
Approval details
- PMA number
- P010012
- Supplement
- S176
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2008-03-12
- Decision date
- 2008-04-17
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR AN UPDATED HEADER CONFIGURATION FOR THE CONFIENT AND LIVIAN DEVICE FAMILIES TO INCLUDE CHANGED SETSCREWS, SEAL PLUGS, AND LEFT VENTRICULAR RING LEAD WIRE ROUTING (LIVIAN ONLY) AS WELL AS THE ADDITION OF A NEW MODEL TORQUE WRENCH.
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