ESSURE SYSTEM
FDA premarket approval P020014/S039 · decided 2012-12-20
Approval details
- PMA number
- P020014
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2012-11-19
- Decision date
- 2012-12-20
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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