This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Device | Axonics Sacral Neuromodulation System |
Generic Name | Stimulator, Electrical, Implantable, For Incontinence |
Applicant | 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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2023-01-10 |
Decision Date | 2023-02-01 |
PMA | P180046 |
Supplement | S064 |
Product Code | EZW |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, 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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Change The Hermetic Welding Process Parameters For The IPG Model 4101 |
Supplement Number | Date | Supplement Type |
---|---|---|
P180046 | Original Filing | |
S064 | 2023-01-10 | 30-day Notice |
S063 | ||
S062 | 2022-09-29 | Normal 180 Day Track |
S061 | 2022-09-19 | Normal 180 Day Track |
S060 | 2022-08-15 | 30-day Notice |
S059 | 2022-08-11 | 30-day Notice |
S058 | ||
S057 | 2022-06-30 | 30-day Notice |
S056 | ||
S055 | 2022-04-15 | 30-day Notice |
S054 | ||
S053 | ||
S052 | 2022-03-24 | 30-day Notice |
S051 | 2022-02-07 | 30-day Notice |
S050 | 2022-01-14 | 30-day Notice |
S049 | 2022-01-05 | 30-day Notice |
S048 | ||
S047 | 2021-12-15 | 30-day Notice |
S046 | ||
S045 | 2021-12-07 | 30-day Notice |
S044 | ||
S043 | 2021-10-27 | 30-day Notice |
S042 | 2021-10-18 | 30-day Notice |
S041 | ||
S040 | ||
S039 | ||
S038 | ||
S037 | 2021-04-26 | 30-day Notice |
S036 | ||
S035 | ||
S034 | 2021-02-25 | 30-day Notice |
S033 | 2021-02-16 | 30-day Notice |
S032 | 2021-02-08 | 30-day Notice |
S031 | 2021-02-01 | 30-day Notice |
S030 | 2021-02-01 | 30-day Notice |
S029 | 2021-01-25 | 30-day Notice |
S028 | ||
S027 | ||
S026 | 2020-11-05 | Real-time Process |
S025 | ||
S024 | ||
S023 | 2020-10-06 | 30-day Notice |
S022 | 2020-10-02 | 30-day Notice |
S021 | 2020-08-24 | 30-day Notice |
S020 | ||
S019 | 2020-07-02 | 30-day Notice |
S018 | 2020-06-16 | 30-day Notice |
S017 | 2020-06-12 | 30-day Notice |
S016 | 2020-06-05 | 30-day Notice |
S015 | ||
S014 | ||
S013 | ||
S012 | ||
S011 | 2020-04-02 | Normal 180 Day Track |
S010 | 2020-03-16 | 30-day Notice |
S009 | 2020-03-11 | 30-day Notice |
S008 | 2020-03-06 | 30-day Notice |
S007 | 2020-03-06 | 30-day Notice |
S006 | ||
S005 | 2020-01-31 | 30-day Notice |
S004 | ||
S003 | 2020-01-17 | 30-day Notice |
S002 | ||
S001 |
Device ID | PMA | Supp |
---|---|---|
10810005340486 | P180046 | 000 |
10810005340431 | P180046 | 015 |
10810005340424 | P180046 | 015 |
10810005340455 | P180046 | 038 |
10810005340479 | P180046 | 056 |
10810005340578 | P180046 | 086 |