PMA P900023S027

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S027
Product code: DSQ
Decision date: 1998-05-28
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for a change in the manufacturing process to allow the outflow connector to be annealed prior to assembly of the blood pump.

Current openFDA PMA Record#

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S027
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1998-05-28
Decision code: APPR
Date received: 1998-04-02
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the manufacturing process to allow the outflow connector to be annealed prior to assembly of the blood pump.