| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002968685 | 3002968685 | AXONICS, INC. | 1 | Y | 2026-01-01 | 15515 Sand Canyon Ave Irvine CA US 92618 |
| 3002968685 | 3002968685 | AXONICS MODULATION TECHNOLOGIES, INC. | 1 | N | 2020-04-25 | 26 Technology Dr. Irvine CA US 92618 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10810005340455 | Axonics - Neurostimulator | +1 (877) 929-6642 | customersupport@axonics.com |
| 10810005340486 | Axonics - Curved Stylet | +1 (877) 929-6642 | customersupport@axonics.com |
| 10810005340493 | Bulkamid - Bulkamid 3mL | +1 (877) 929-6642 | customersupport@axonics.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 334747 | 1888768123 | P190006 | Axonics Sacral Neuromodulation System | QON | 2019-09-06 |
| 233186 | 1933912368 | P190006 | Axonics Sacral Neuromodulation System | QON | 2019-09-06 |
| 334747 | 1332365242 | P180046 | Axonics Sacral Neuromodulation System | EZW | 2019-11-13 |
| 233186 | 1631311889 | P180046 | Axonics Sacral Neuromodulation System | EZW | 2019-11-13 |
| 334747 | 1712452773 | P170023 | Bulkamid Urethral Bulking System | LNM | 2020-01-28 |
| 233186 | 1748390785 |
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Trac...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Trac...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Trac...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Trac...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS013 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS059 Date Received08/11/2022 Decision Date09/08/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS059 Date Received08/11/2022 Decision Date09/08/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS011 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS009 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS010 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS057 Date Received06/30/2022 Decision Date07/20/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS057 Date Received06/30/2022 Decision Date07/20/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS055 Date Received04/15/2022 Decision Date05/13/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS055 Date Received04/15/2022 Decision Date05/13/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS052 Date Received03/24/2022 Decision Date04/20/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS052 Date Received03/24/2022 Decision Date04/20/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS051 Date Received02/07/2022 Decision Date03/03/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS051 Date Received02/07/2022 Decision Date03/03/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.
AXONICS, INC.
AXONICS, INC.
AXONICS, INC.
AXONICS, INC.
AXONICS, INC.
2025-02-05
2024-07-29
2023-09-08
2023-08-30
2022-06-14
2022-03-11
2020-11-03
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