PMA P130018S001
- Device
- PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
- Applicant
- Uromedica, Inc.
- PMA number
- P130018
- Supplement
- S001
- Product code
- EZY
- Decision date
- 2016-11-02
- Classification
- Device, Incontinence, Mechanical/hydraulic
- Generic name
- Device, incontinence, mechanical/hydraulic
- Approval order statement
- Approval of the protocol for the post-approval study protocol.
Current openFDA PMA Record#
- Device
- PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
- Applicant
- Uromedica, Inc.
- PMA number
- P130018
- Supplement
- S001
- Product code
- EZY
- Generic name
- Device, incontinence, mechanical/hydraulic
- Decision date
- 2016-11-02
- Decision code
- APPR
- Date received
- 2015-12-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the protocol for the post-approval study protocol.