|
Device | NG4 Family of Pulse Generators ICDS. |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S385 |
Date Received | 10/28/2016 |
Decision Date | 05/02/2017 |
Product Code |
LWS |
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 |