PMA P020014S020
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S020
- Product code
- HHS
- Decision date
- 2008-09-11
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR A MODIFICATION TO SPECIFICATIONS OF THE DRY FLOW INTRODUCER AND THE ADDITION OF A BACK-UP BOND IN THE DETACHMENT MECHANISM.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S020
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2008-09-11
- Decision code
- APPR
- Date received
- 2008-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO SPECIFICATIONS OF THE DRY FLOW INTRODUCER AND THE ADDITION OF A BACK-UP BOND IN THE DETACHMENT MECHANISM.