|
Device | INGENIO 2 MRI PACEMAKERS. |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
BOSTONSCIENTIFIC |
4100 hamline avenue north |
st paul, MN 55112 |
|
PMA Number | P150012 |
Supplement Number | S004 |
Date Received | 05/06/2016 |
Decision Date | 07/14/2016 |
Product Codes |
LWP
NVN
|
Advisory Committee |
Cardiovascular |
Supplement Type | real-time process |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
Approval for design changes to the accelerometer component and associated changes. |