ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA premarket approval P900023/S037 · decided 2003-04-28
Approval details
- PMA number
- P900023
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2002-07-01
- Decision date
- 2003-04-28
- Days to decision
- 301 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE ADDITION OF THE AB5000 PNEUMATIC DRIVE CONSOLE TO THE BVS 5000 DEVICE SYSTEM. THE AB5000 CONSOLE CAN BE USED TO DRIVE ONE OR TWO BVS 5000 BLOOD PUMPS; IT CAN BE USED EITHER IN THE HOSPITAL OR FOR TRANSPORT OF PATIENTS BETWEEN HOSPITALS.
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