|
Device | NG4 Family of Pulse Generators CRT-DS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S436 |
Date Received | 10/28/2016 |
Decision Date | 05/02/2017 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for NG4 models of ICD and CRT-D devices with new therapy and diagnostic features. |
Post-Approval Study | Show Report Schedule and Study Progress |