PMA P900023

Device: ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S052
Product code: DSQ
Decision date: 2012-06-26
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR CORRECTION OF THE AB5000 DRIVER FAILURE NOTIFICATION ALARM, ADDITION OF A DELAY CIRCUIT TO THE EXTERNAL AB PORTABLE POWER SUPPLY, AND CORRECTION TO THE IPULSE DRIVER PLENUM SEAL.

Current openFDA PMA Record#

Device: ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S052
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2012-06-26
Decision code: APPR
Date received: 2011-10-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CORRECTION OF THE AB5000 DRIVER FAILURE NOTIFICATION ALARM, ADDITION OF A DELAY CIRCUIT TO THE EXTERNAL AB PORTABLE POWER SUPPLY, AND CORRECTION TO THE IPULSE DRIVER PLENUM SEAL.