Axonics Sacral Neuromodulation (SNM) System for Bowel Control
FDA premarket approval P190006/S036 · decided 2021-11-03
Approval details
- PMA number
- P190006
- Supplement
- S036
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axonics Sacral Neuromodulation (SNM) System for Bowel Control
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-04-26
- Decision date
- 2021-11-03
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for an alternate manufacturing site (Grand Rapids, MI) to source sterile pouches.
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