|
Device | 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 | S028 |
Date Received | 07/01/2013 |
Decision Date | 09/25/2013 |
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 A DESIGN CHANGE TO THE UNIVERSAL BATTERY CHARGER. |