|
Device | Symplicity Spyral™ Renal Denervation System |
Generic Name | Ablation catheter, renal denervation |
Applicant | Medtronic Inc. 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P220026 |
Date Received | 11/08/2022 |
Decision Date | 11/17/2023 |
Product Code |
QYI |
Docket Number | 23M-5472 |
Notice Date | 12/15/2023 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02439749
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The Symplicity Spyral Multi-Electrode Renal Denervation Catheter and the Symplicity G3 RF Generator are indicated to reduce blood pressure as an adjunctive treatment in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S009 |