PMA P900023S032

Device: ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S032
Product code: DSQ
Decision date: 2000-05-12
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for the Instructions for Use for the BVS 5000 Cannulae that were modified to address specific concerns associated with the Hemashield graft and the silicone-coated graft.

Current openFDA PMA Record#

Device: ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S032
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2000-05-12
Decision code: APPR
Date received: 2000-03-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Instructions for Use for the BVS 5000 Cannulae that were modified to address specific concerns associated with the Hemashield graft and the silicone-coated graft.