|
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 | 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 |
Approval Order Statement a reduction of cleanroom environmental monitoring testing locations |