|
Device | Reliance 4- Front Lead Family and Suture Sleeve Accessory |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S145 |
Date Received | 12/12/2017 |
Decision Date | 05/04/2018 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02071173
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the RELIANCE 4-FRONT lead family and suture sleeve accessory (Model 6403). |
Post-Approval Study | Show Report Schedule and Study Progress |