|
Device | ReCor Paradise® Ultrasound Renal Denervation System |
Generic Name | Ablation catheter, renal denervation |
Applicant | ReCor Medical, Inc. 1049 Elwell Court Palo Alto, CA 94303 |
PMA Number | P220023 |
Supplement Number | S002 |
Date Received | 12/08/2023 |
Decision Date | 02/05/2024 |
Product Code |
QYI |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02649426
|
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 protocol for the US arm of the Global Paradise System Post Approval Study |