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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSymplicity Spyral™ Renal Denervation System
Generic NameAblation catheter, renal denervation
ApplicantMedtronic Inc.
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP220026
Date Received11/08/2022
Decision Date11/17/2023
Product Code QYI 
Docket Number 23M-5472
Notice Date 12/15/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT02439749
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S006 S007 
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