|
Device | ESSENTIO MRI; PROPONENT MRI; ACCOLADE 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 | S015 |
Date Received | 09/02/2016 |
Decision Date | 09/29/2016 |
Product Codes |
LWP
NVN
|
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
Addition of a software interface between the traceability system software and the braze oven equipment for the feedthru component braze process. |