Axonics Sacral Neuromodulation System (Urinary)
FDA premarket approval P180046/S061 · decided 2022-11-01
Approval details
- PMA number
- P180046
- Supplement
- S061
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axonics Sacral Neuromodulation System (Urinary)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-09-19
- Decision date
- 2022-11-01
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- 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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