- Device
- ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S041
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2015-06-29
- Decision code
- APPR
- Date received
- 2014-03-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGING THE ESSURE INSTRUCTIONS FOR USE TO REPLACE THE PREVIOUSLY APPROVED MODIFIED HYSTEROSALPINGOGRAM CONFIRMATION TEST WITH THE TRANSVAGINAL ULTRASOUND/ HYSTEROSALPINGOGRAM CONFIRMATION TEST ALGORITH