PMA P900023S030

Device: ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S030
Product code: DSQ
Decision date: 2000-03-13
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for using model EWS300P-24 AC/DC Converter manufactured by Lambda, Melville, NY as an alternate AC/DC Converter in the BVS 5000 and BVS 5000i consoles.

Current openFDA PMA Record#

Device: ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S030
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2000-03-13
Decision code: APPR
Date received: 1999-10-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for using model EWS300P-24 AC/DC Converter manufactured by Lambda, Melville, NY as an alternate AC/DC Converter in the BVS 5000 and BVS 5000i consoles.