Axonics Sacral Neuromodulation System
FDA premarket approval P180046/S067 · decided 2023-04-04
Approval details
- PMA number
- P180046
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-03-08
- Decision date
- 2023-04-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Change in inspection process of the Axonics IPG (models 1101 and 5101) to remove the weight inspection from the current inspection process.
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