|
Device | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S024 |
Date Received | 08/08/2012 |
Decision Date | 10/05/2012 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |