PMA P020014S026
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S026
- Product code
- HHS
- Decision date
- 2009-07-16
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT AVAILMED S.A. DE C.V., TIJUANA, MEXICO.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S026
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2009-07-16
- Decision code
- APPR
- Date received
- 2009-05-15
- 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 AVAILMED S.A. DE C.V., TIJUANA, MEXICO.