CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S032 · decided 2011-02-24
Approval details
- PMA number
- P020014
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2010-12-28
- Decision date
- 2011-02-24
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE DUCKBILL VALVE OF THE VALVED INTRODUCER AND CHANGES TO THE LENGTH OF THE DELIVERY WIRE.
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