|
Device | INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
BOSTONSCIENTIFIC |
4100 hamline avenue north |
st paul, MN 55112 |
|
PMA Number | P150012 |
Supplement Number | S063 |
Date Received | 06/11/2018 |
Decision Date | 07/05/2018 |
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 new molding preparation equipment with updated software, application of existing overmolding equipment already in use for other leads, and duplication of existing process monitoring testing to monitor output of the added equipment. |