|
Trade Name | Software Maintenance Release |
Classification Name | stimulator, carotid sinus nerve |
Generic Name | stimulator, carotid sinus nerve |
Regulation Number | 870.3850 |
Applicant |
CVRx, INC. |
9201 west broadway avenue |
suite 650 |
minneapolis, MN 55445 |
|
HDE Number | H130007 |
Supplement Number | S002 |
Date Received | 07/19/2017 |
Decision Date | 10/12/2017 |
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 a software maintenance release for the model 9010 programmer. |