PMA P060040S024

Device: THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S024
Product code: DSQ
Decision date: 2012-10-05
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL TO EXTEND THE SHELF-LIFE OF BOTH THE HEARTMATE II (HM II) SEALED OUTFLOW GRAFT AND THE SEALED INFLOW CONDUIT FROM THE CURRENT LABELING OF THREE YEARS TO FIVE YEARS.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S024
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2012-10-05
Decision code: APPR
Date received: 2012-08-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO EXTEND THE SHELF-LIFE OF BOTH THE HEARTMATE II (HM II) SEALED OUTFLOW GRAFT AND THE SEALED INFLOW CONDUIT FROM THE CURRENT LABELING OF THREE YEARS TO FIVE YEARS.