- Device
- ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S019
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2008-10-08
- Decision code
- APPR
- Date received
- 2008-06-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIGENICS US, INC., SANTA TERESA, NEW MEXICO.