|
Device | THORATEC HEARTMATE II LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S015 |
Date Received | 02/13/2012 |
Decision Date | 06/05/2012 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO REFLECT THE POST-APPROVAL STUDY FINDINGS FOR THE BRIDGE-TO-TRANSPLANT INDICATION. |