CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S012 · decided 2007-06-15
Approval details
- PMA number
- P020014
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- 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
- 2006-03-17
- Decision date
- 2007-06-15
- Days to decision
- 455 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR DESIGN AND MATERIAL CHANGES TO THE MICRO-INSERT, DELIVERY CATHETER, AND INTRODUCER OF THE ESSURE SYSTEM.
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