|
Device | HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S044 |
Date Received | 05/29/2014 |
Decision Date | 06/27/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00751972
|
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE INFORMATION RELATED TO BATTERY PERFORMANCE. |
Post-Approval Study | Show Report Schedule and Study Progress |