PMA P900023S026
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S026
- Product code
- DSQ
- Decision date
- 1998-02-02
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval to change the current BVS battery to a Hawker Genesis HrD 13 Ah battery, Model G12V13Ah10EP.
Current openFDA PMA Record#
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S026
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1998-02-02
- Decision code
- APPR
- Date received
- 1998-01-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to change the current BVS battery to a Hawker Genesis HrD 13 Ah battery, Model G12V13Ah10EP.