PMA P900023S028
- Device
- ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S028
- Product code
- DSQ
- Decision date
- 1999-11-24
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a 10mm Arterial Cannula with 10mm Hemashield(R) woven graft.
Current openFDA PMA Record#
- Device
- ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S028
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1999-11-24
- Decision code
- APPR
- Date received
- 1999-04-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a 10mm Arterial Cannula with 10mm Hemashield(R) woven graft.