|
Device | Optisure High Voltage Leads |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S131 |
Date Received | 03/12/2020 |
Decision Date | 05/15/2020 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02235545
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) and to discontinue the Externalization and Abrasion sub-study. |