Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ESSENTIO MRI, PROPONENT MRI, 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 | S018 |
Date Received | 11/03/2016 |
Decision Date | 11/30/2016 |
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
Addition of an alternate supplier of titanium for pulse generator case halves. |
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