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 | S071 |
Date Received | 07/27/2023 |
Decision Date | 10/23/2023 |
Product Code |
EZW |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This 180-day PMA supplement requested approval for expansion of the current MRI labeling to permit a 1.5T MRI scan on the 4101/5101 IPG connected to a tined lead with high impedance (“a broken lead”). |
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