PMA P900023S034
- Device
- ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S034
- Product code
- DSQ
- Decision date
- 2001-03-12
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL TO REVISE THE LABELING TO INCLUDE CANNULATION OF THE LEFT VENTRICULAR APEX WITH ANY OF THE ATRIAL CANNULAE.
Current openFDA PMA Record#
- Device
- ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S034
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2001-03-12
- Decision code
- APPR
- Date received
- 2000-11-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO REVISE THE LABELING TO INCLUDE CANNULATION OF THE LEFT VENTRICULAR APEX WITH ANY OF THE ATRIAL CANNULAE.