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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 | S074 |
Date Received | 09/12/2023 |
Decision Date | 10/11/2023 |
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 approval for an updated vacuum bakeout process for the Axonics IPG Model 4101 Hermetic Enclosure (P/N 186-0061-001) |