Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Symplicity Spyral' Multi-Electrode Renal Denervation Catheter
• Generic Name: Ablation catheter, renal denervation
• Applicant: Medtronic, Inc.; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P220026
• Supplement Number: S007
• Date Received: 04/26/2024
• Decision Date: 05/08/2024
• Product Code: QYI
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
a reduction of cleanroom environmental monitoring testing locations