|
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 | S055 |
Date Received | 03/31/2016 |
Decision Date | 04/28/2016 |
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 Add a new sterilization chamber for certain components of the Thoratec HeartMate II® Ventricular Assist System. |