|
Device | S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD |
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 | S108 |
Date Received | 05/02/2018 |
Decision Date | 06/01/2018 |
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 an additional supplier for the raw stainless steel material for battery interconnect tabs used in Tachy and Subcutaneous Implantable Cardioverter Defibrillator pulse generator devices. |