FDA Registration
Active
🇺🇸 United States
ProACT Adjustable Continence Therapy for Men
Reg #: 3003477176
·
FEI: 3003477176
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UROMEDICA, INC.
- Registration Number
- 3003477176
- FEI Number
- 3003477176
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1840 Berkshire Ln N
- City
- PLYMOUTH
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- PMA Number
- P130018
Owner / Operator
- Firm Name
- UROMEDICA, INC.
- Operator Number
- 9047760
- Address
- 1840 BERKSHIRE LN. NORTH, --
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
- Correspondent
- Timothy C Cook
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Incontinence, Mechanical/Hydraulic | EZY | Class 3 | Gastroenterology, Urology | No | 2017-08-24 |
Proprietary Names
ProACT Adjustable Continence Therapy for Men
ProACT Implantation Instrument Set
ProACT Tissue Expanding Device II
ProACT Blunt Trocar
Establishment Types
Manufacture Medical Device