FEMSOFT URETHRAL INSERT

FDA premarket approval P990002/S001 · decided 2000-12-28

Approval details

PMA number

P990002

Supplement

S001

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

FEMSOFT URETHRAL INSERT

Generic name

Transurethral occlusion insert, urinary incontinence-control, female

Applicant

Rochester Medical Corp.

Date received

2000-12-14

Decision date

2000-12-28

Days to decision

14 days

Decision code

APPR

Product code

OCK

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Stewartville, MN

Statement

APPROVAL TO ADD THE PRECAUTION "AVOID HEAT" TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FEMSOFT(R) INSERT AND IS INDICATED FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN ADULT FEMALES.

510(k) clearances by this applicant