Essure System for Permanent Birth Control
FDA premarket approval P020014/S051 · decided 2018-04-09
Approval details
- PMA number
- P020014
- Supplement
- S051
- Supplement type
- Special (Immediate 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
- 2018-04-04
- Decision date
- 2018-04-09
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- Approval for a change in the title of the "Patient-Doctor Discussion Checklist" to "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement, and for revisions to the patient insert card.
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