|
Device | HEARTWARE VENTRICULAR ASSIST SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S042 |
Date Received | 05/13/2014 |
Decision Date | 06/11/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00751972
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement UPDATE TO THE WELDING PROCESS AT HARDING ENERGY, INC FOR THE NICKEL METAL HYDRIDE BATTERY USED IN THE DEVICE CONTROLLER. |
Post-Approval Study | Show Report Schedule and Study Progress |