|
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 | S044 |
Date Received | 09/14/2015 |
Decision Date | 10/14/2015 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN ALTERNATE SUPPLIER FOR A CRITICAL COMPONENT IN THE HEARTMATE II LVAS POCKET CONTROLLER. |