PMA P990002S002
- Device
- FEMSOFT URETHRAL INSERT
- Applicant
- Rochester Medical Corp.
- PMA number
- P990002
- Supplement
- S002
- Product code
- OCK
- Decision date
- 2013-03-21
- Classification
- Transurethral Occlusion Insert, Urinary Incontinence-control, Female
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS.
Current openFDA PMA Record#
- Device
- FEMSOFT URETHRAL INSERT
- Applicant
- Rochester Medical Corp.
- PMA number
- P990002
- Supplement
- S002
- Product code
- OCK
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Decision date
- 2013-03-21
- Decision code
- APPR
- Date received
- 2012-12-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS.