|
Device | THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S042 |
Date Received | 05/07/2015 |
Decision Date | 06/04/2015 |
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 IMPLEMENTATION OF A SUPPLIERS FACILITY RELOCATION FOR CERTAIN COMPONENTS OF THE THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM AND THORATEC VENTRICULAR ASSIST DEVICE SYSTEM. |