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 (Urinary) |
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 | S061 |
Date Received | 09/19/2022 |
Decision Date | 11/01/2022 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Cirtec Medical Corporation, 99 Print Shop Road Enfield, CT 06082 as an alternate contract ethylene oxide sterilization facility for the Axonics Neurostimulator, Model 4101. |
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