PMA P900023S031
- Device
- ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S031
- Product code
- DSQ
- Decision date
- 2000-04-14
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console.
Current openFDA PMA Record#
- Device
- ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S031
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2000-04-14
- Decision code
- APPR
- Date received
- 1999-10-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console.