PMA P900023S016

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S016
Product code: DSQ
Decision date: 1996-03-12
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A CHANGE TO A COMPONENT IN THE BVS 5000 CONSOLE, THE HONEYWELL SOLENOID VALVE , AND TO EXTEND THE RECOMMENDED REPLACEMENT ITME

Current openFDA PMA Record#

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S016
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1996-03-12
Decision code: APPR
Date received: 1995-08-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO A COMPONENT IN THE BVS 5000 CONSOLE, THE HONEYWELL SOLENOID VALVE , AND TO EXTEND THE RECOMMENDED REPLACEMENT ITME