CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
FDA premarket approval P020014/S036 · decided 2012-04-19
Approval details
- PMA number
- P020014
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Generic name
- Transcervical contraceptive tubal occlusion device
- Applicant
- Bayer Pharma AG
- Date received
- 2011-10-05
- Decision date
- 2012-04-19
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- HHS
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRECISION WIRE COMPONENTS, TUALATIN, OREGON.
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