PMA P900023S033
- Device
- ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S033
- Product code
- DSQ
- Decision date
- 2000-06-22
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A 36 FRENCH POLYURETHANE ARTERIAL CANNULA WITH A STAINLESS STEEL WIRE REINFORCED COIL AND A 10 MM HEMASHIELD(R) GRAFT.
Current openFDA PMA Record#
- Device
- ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S033
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2000-06-22
- Decision code
- APPR
- Date received
- 2000-05-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A 36 FRENCH POLYURETHANE ARTERIAL CANNULA WITH A STAINLESS STEEL WIRE REINFORCED COIL AND A 10 MM HEMASHIELD(R) GRAFT.