PMA P220026S001

Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Symplicity G3™ Renal Devervation RF Generator
Applicant: Medtronic, Inc.
PMA number: P220026
Supplement: S001
Product code: QYI
Decision date: 2024-02-15
Classification: Cardiovascular
Generic name: Ablation catheter, renal denervation
Approval order statement: Approval of the protocol for the post-approval study Spyral AFFIRM (New-Enrollment Registry Study)

Current openFDA PMA Record#

Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Symplicity G3™ Renal Devervation RF Generator
Applicant: Medtronic, Inc.
PMA number: P220026
Supplement: S001
Product code: QYI
Generic name: Ablation catheter, renal denervation
Decision date: 2024-02-15
Decision code: APPR
Date received: 2023-12-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study Spyral AFFIRM (New-Enrollment Registry Study)