PMA P900023S025

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S025
Product code: DSQ
Decision date: 1998-03-13
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for four new 32 French atrial cannulae which are 90 degrees Bend with Lighthouse Tip, Straight with Lighthouse Tip, 90 degrees Bend with Beveled Tip, and Straight with Beveled Tip.

Current openFDA PMA Record#

Device: ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S025
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1998-03-13
Decision code: APPR
Date received: 1997-11-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for four new 32 French atrial cannulae which are 90 degrees Bend with Lighthouse Tip, Straight with Lighthouse Tip, 90 degrees Bend with Beveled Tip, and Straight with Beveled Tip.