|
Device | ESSENTIO™ MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT™ MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S119 |
Date Received | 10/08/2021 |
Decision Date | 10/21/2021 |
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 Automate a battery component cleaning process. |