Axonics Sacral Neuromodulation (SNM) System for Bowel Control
FDA premarket approval P180046/S031 · decided 2021-03-02
Approval details
- PMA number
- P180046
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axonics Sacral Neuromodulation (SNM) System for Bowel Control
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2021-02-01
- Decision date
- 2021-03-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- 1. Changes to manufacturing instructions for a critical device component at a contract manufacturer;2. New inspection procedures for a critical device component; and3. Changes made to the temperature sensor calibration of a critical device component.
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