PMA P020014S043
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S043
- Product code
- HHS
- Decision date
- 2015-06-09
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAYER HEALTHCARE SRL IN HEREDIA, COSTA RICA.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S043
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2015-06-09
- Decision code
- APPR
- Date received
- 2014-11-24
- 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 LOCATED AT BAYER HEALTHCARE SRL IN HEREDIA, COSTA RICA.