ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM
FDA premarket approval P900023/S030 · decided 2000-03-13
Approval details
- PMA number
- P900023
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 1999-10-07
- Decision date
- 2000-03-13
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for using model EWS300P-24 AC/DC Converter manufactured by Lambda, Melville, NY as an alternate AC/DC Converter in the BVS 5000 and BVS 5000i consoles.
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