PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

Device, Incontinence, Mechanical/hydraulic

FDA Premarket Approval P130018

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the proact adjustable continence therapy for men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (turp) and who have failed to respond adequately to conservative therapy.

DevicePROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
Classification NameDevice, Incontinence, Mechanical/hydraulic
Generic NameDevice, Incontinence, Mechanical/hydraulic
ApplicantUROMEDICA INC
Date Received2013-06-17
Decision Date2015-11-24
Notice Date2017-02-27
PMAP130018
SupplementS
Product CodeEZY
Docket Number15M-4473
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address UROMEDICA INC 1840 Berkshire Lane N plymouth, MN 55441
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P130018Original Filing
S002 2021-05-18 30-day Notice
S001 2015-12-21 Normal 180 Day Track No User Fee

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