PMA P180046S011
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S011
- Product code
- EZW
- Decision date
- 2020-07-01
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Approval for the addition of 3T MRI RF Body Coil Conditional to the labeling.
Current openFDA PMA Record#
- Device
- Axonics Sacral Neuromodulation System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180046
- Supplement
- S011
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2020-07-01
- Decision code
- APPR
- Date received
- 2020-04-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of 3T MRI RF Body Coil Conditional to the labeling.