CONCEPTUS ESSURE SYSTEM
FDA premarket approval P020014/S038 · decided 2012-10-02
Approval details
- PMA number
- P020014
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCEPTUS ESSURE SYSTEM
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2012-04-16
- Decision date
- 2012-10-02
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR A MATERIAL CHANGE AND A MINOR PROCESS CHANGE. THE USE OF NEW CARBOTHANE MATERIALS IN THE DELIVERY CATHETER WITH THE NEW HYDROPHILIC COATING AND A CHANGE IN OPERATING TEMPERATURE.
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