|
Trade Name | CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) |
Classification Name | right ventricular bypass (assist) device |
Generic Name | right ventricular bypass (assist) device |
Applicant |
Abbott |
6035 stoneridge drive |
pleasanton, CA 94588 |
|
HDE Number | H070004 |
Supplement Number | S014 |
Date Received | 01/20/2015 |
Decision Date | 03/26/2015 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the centrimag primary console lmcebpx pcb and the centrimag primary console rechargeable lithium ion battery pack. |