|
Device | Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
Generic Name | Ablation catheter, renal denervation |
Applicant | Medtronic Inc. 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P220026 |
Supplement Number | S004 |
Date Received | 02/02/2024 |
Decision Date | 02/29/2024 |
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 |
Approval Order Statement introduction of a Radio Frequency Identification (RFID) tag screening as part of incoming inspection at the cable sub-assembly supplier |