ProACT Adjustable Continence Therapy for Men
FDA premarket approval P130018/S002 · decided 2021-06-10
Approval details
- PMA number
- P130018
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ProACT Adjustable Continence Therapy for Men
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Uromedica, Inc.
- Date received
- 2021-05-18
- Decision date
- 2021-06-10
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Update the sterilization dose auditing frequency from every three to 12 months.
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