PMA P900023S029

Device: BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S029
Product code: DSQ
Decision date: 1999-05-19
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval to modify the Operator's Manual to add information about transporting a patient to another institution while on BVS 5000 support, and to add information about the console display that has occurred during weaning from the device.

Current openFDA PMA Record#

Device: BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S029
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1999-05-19
Decision code: APPR
Date received: 1999-04-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to modify the Operator's Manual to add information about transporting a patient to another institution while on BVS 5000 support, and to add information about the console display that has occurred during weaning from the device.