|
Device | Essentio, Proponent, 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 | S080 |
Date Received | 06/20/2019 |
Decision Date | 09/18/2019 |
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 hardware modifications to the IS-1 lead bore cavity and spring coil in the IS-1 pulse generator (PG) header for all pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) within the Accolade family and a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) within the NG3 and NG4 families. |