PMA P990002S001
- Device
- FEMSOFT URETHRAL INSERT
- Applicant
- Rochester Medical Corp.
- PMA number
- P990002
- Supplement
- S001
- Product code
- OCK
- Decision date
- 2000-12-28
- Classification
- Transurethral Occlusion Insert, Urinary Incontinence-control, Female
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Approval order 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.
Current openFDA PMA Record#
- Device
- FEMSOFT URETHRAL INSERT
- Applicant
- Rochester Medical Corp.
- PMA number
- P990002
- Supplement
- S001
- Product code
- OCK
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Decision date
- 2000-12-28
- Decision code
- APPR
- Date received
- 2000-12-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.