|
Device | ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTONSCIENTIFIC 4100 HAMLINE AVENUE NORTH ST PAUL, MN 55112 |
PMA Number | P150012 |
Supplement Number | S096 |
Date Received | 07/02/2020 |
Decision Date | 08/26/2020 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for labeling updates for the ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead based on the SAMURAI and INGEVITY clinical studies. |