PMA P900023S039

Device: ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S039
Product code: DSQ
Decision date: 2003-12-23
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR AN ADDITIONAL LABEL IN THE FORM OF A PACKAGING STICKER STATING, "ONLY USE THREADED RESTRAINTS WITH THE AB5000 VENTRICLE. USE OF NON-THREADED CANNULA RESTRAINTS MAY RESULT IN: 1) CANNULAE BECOMING DISCONNECTED FROM THE VENTRICLE, AND 2) THROMBUS FORMATION."

Current openFDA PMA Record#

Device: ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S039
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2003-12-23
Decision code: APPR
Date received: 2003-12-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN ADDITIONAL LABEL IN THE FORM OF A PACKAGING STICKER STATING, "ONLY USE THREADED RESTRAINTS WITH THE AB5000 VENTRICLE. USE OF NON-THREADED CANNULA RESTRAINTS MAY RESULT IN: 1) CANNULAE BECOMING DISCONNECTED FROM THE VENTRICLE, AND 2) THROMBUS FORMATION."