PMA P900023S046

Device: AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S046
Product code: DSQ
Decision date: 2007-04-24
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE AB5000 VENTRICLE CANNULA RESTRAINT SYSTEM, EXTENDED SHELF LIFE (2 YEARS) FOR THE AB5000 VENTRICLE, AND RECLASSIFICATION OF A PRECAUTION TO A WARNING FOR THE BVS 5000.

Current openFDA PMA Record#

Device: AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S046
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2007-04-24
Decision code: APPR
Date received: 2006-10-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE AB5000 VENTRICLE CANNULA RESTRAINT SYSTEM, EXTENDED SHELF LIFE (2 YEARS) FOR THE AB5000 VENTRICLE, AND RECLASSIFICATION OF A PRECAUTION TO A WARNING FOR THE BVS 5000.