PMA P900023S023
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S023
- Product code
- DSQ
- Decision date
- 1997-09-03
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for use of a 42 French atrial and a 42 French arterial cannula to be used with the BVS 5000(R) Bi-Ventricular Support System.
Current openFDA PMA Record#
- Device
- ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S023
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1997-09-03
- Decision code
- APPR
- Date received
- 1997-06-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of a 42 French atrial and a 42 French arterial cannula to be used with the BVS 5000(R) Bi-Ventricular Support System.