ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S043 · decided 2005-03-11
Approval details
- PMA number
- P900023
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2005-01-18
- Decision date
- 2005-03-11
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE ADDITION OF FOUR NEW INFLOW CANNULAE (32/42 FR APICAL CANNULA WITH SIDE HOLES AND 32/42 FR APICAL CANNULA WITHOUT SIDE HOLES) FOR USE WITH THE BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND THE AB5000 CIRCULATORY SUPPORT SYSTEM.
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