Axonics Sacral Neuromodulation System
FDA premarket approval P190006/S068 · decided 2023-05-16
Approval details
- PMA number
- P190006
- Supplement
- S068
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axonics Sacral Neuromodulation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-04-18
- Decision date
- 2023-05-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Change in the manufacturing process regarding the method of surface texturing, leak testing, and cleaning.
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