PMA P130018S002
- Device
- ProACT Adjustable Continence Therapy for Men
- Applicant
- Uromedica, Inc.
- PMA number
- P130018
- Supplement
- S002
- Product code
- EZY
- Decision date
- 2021-06-10
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Update the sterilization dose auditing frequency from every three to 12 months.
Current openFDA PMA Record#
- Device
- ProACT Adjustable Continence Therapy for Men
- Applicant
- Uromedica, Inc.
- PMA number
- P130018
- Supplement
- S002
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2021-06-10
- Decision code
- OK30
- Date received
- 2021-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the sterilization dose auditing frequency from every three to 12 months.