ESSURE SYSTEM
FDA premarket approval P020014 · decided 2002-11-04
Approval details
- PMA number
- P020014
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2002-04-22
- Decision date
- 2002-11-04
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- Yes
- Location
- Berlin
- Statement
- APPROVAL FOR THE ESSURE SYSTEM. THE DEVICE IS INDICATED FOR PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES.
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