|
Device | Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
BOSTONSCIENTIFIC |
4100 hamline avenue north |
st paul, MN 55112 |
|
PMA Number | P150012 |
Supplement Number | S046 |
Date Received | 11/13/2017 |
Decision Date | 12/11/2017 |
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
Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid. |