ESSURE SYSTEM
FDA premarket approval P020014/S046 · decided 2016-11-15
Approval details
- PMA number
- P020014
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2016-05-19
- Decision date
- 2016-11-15
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- Approval for changes to the physicians instructions for use and patient information booklet including a boxed warning and a patient decision checklist.
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