PMA P180046S032
- Device
- Axonics Sacral Neuromodulation (SNM) System for Bowel Control
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S032
- Product code
- EZW
- Decision date
- 2021-03-04
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Updates to quality control procedures and supporting manufacturing equipment.
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation (SNM) System for Bowel Control
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S032
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2021-03-04
- Decision code
- OK30
- Date received
- 2021-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to quality control procedures and supporting manufacturing equipment.