|
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 | S003 |
Date Received | 01/29/2024 |
Decision Date | 02/28/2024 |
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 the addition of an electron beam sterilization line at the existing contract sterilizer location |