ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S013 · decided 1996-01-29
Approval details
- PMA number
- P900023
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 1994-08-31
- Decision date
- 1996-01-29
- Days to decision
- 516 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR INCREASING THE LEFT SIDE FLOW CAPACITY OF THE ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM BY APPROXIMATELY 1 LITE/MINUTE (I.E., FROM 5 LITERS/MINUTE TO APPROXIMATELY 6 LITERS/MINUTE
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