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, 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 | S062 |
Date Received | 05/04/2018 |
Decision Date | 07/17/2018 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for an inner tray redesign for the packaging used for the standard life (SL) Accolade pacemakers.. |
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