ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S041 · decided 2015-06-29
Approval details
- PMA number
- P020014
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2014-03-14
- Decision date
- 2015-06-29
- Days to decision
- 472 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- 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
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