PMA P900023S024

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S024
Product code: DSQ
Decision date: 1997-09-26
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for a change in the manufacturing process to allow the coupling nut 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: S024
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1997-09-26
Decision code: APPR
Date received: 1997-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the manufacturing process to allow the coupling nut to be annealed prior to assembly of the blood pump.