- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S014
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2007-08-07
- Decision code
- APPR
- Date received
- 2007-06-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE FROM CONCEPTUS, INC. IN MOUNTAIN VIEW, CALIFORNIA TO A CONTRACT MANUFACTURER IN CHIHUAHUA, MEXICO.