ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S020 · decided 1996-12-31
Approval details
- PMA number
- P900023
- Supplement
- S020
- 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
- 1996-12-06
- Decision date
- 1996-12-31
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR CHANGING THE TUBING DIAMETER OF THE TUBES LEADING TO/FROM THE LEFT SIDE FLOW TRANSDUCER FROM 1/4 INCH TO 1/16 INCH ID (INNDER DIAMETER) AND CHANGING THE CONSOLE COOLING FAN FROM ONE HAVING A CAPACITY OF 94 CFM (CUBIC FEET PER MINUTE) TO ONE HAVING A CAPACITY OF 55 CFM.
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