Note: 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. |
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Device | Axonics Sacral Neuromodulation System |
Generic Name | Stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant | Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 |
PMA Number | P180046 |
Supplement Number | S083 |
Date Received | 04/05/2024 |
Decision Date | 05/02/2024 |
Product Code |
EZW |
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 the EO sterilization of three pallets in Chambers 5 and 6 at contract sterilizer Parter Sterilization Services |
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