|
Device | Axonics Sacral Neuromodulation System |
Generic Name | Implanted electrical device intended for treatment of fecal incontinence |
Regulation Number | 876.5270 |
Applicant | Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 |
PMA Number | P190006 |
Supplement Number | S073 |
Date Received | 08/28/2023 |
Decision Date | 09/26/2023 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a sterilization chamber. |