|
Device | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S062 |
Date Received | 10/24/2016 |
Decision Date | 12/14/2016 |
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 for design modifications to the 11V Lithium-Ion Backup Battery. |