|
Device | Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
BOSTONSCIENTIFIC |
4100 hamline avenue north |
st paul, MN 55112 |
|
PMA Number | P150012 |
Supplement Number | S058 |
Date Received | 03/26/2018 |
Decision Date | 04/25/2018 |
Product Codes |
NVN
LWP
|
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
Updates to the BET test method. |