|
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 | S054 |
Date Received | 03/28/2016 |
Decision Date | 04/05/2016 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding an informational card related to the backup battery. |