|
Device | ESSENTIO MRI, PROPONENT MRI, and 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 | S100 |
Date Received | 08/13/2020 |
Decision Date | 10/16/2020 |
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 to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging. |