|
Device | EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S107 |
Date Received | 04/17/2018 |
Decision Date | 05/15/2018 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add Boston Scientific as a second supplier for Digital ASIC electrical testing and to implement other minor process updates. |