PMA P020014S032
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S032
- Product code
- HHS
- Decision date
- 2011-02-24
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE DUCKBILL VALVE OF THE VALVED INTRODUCER AND CHANGES TO THE LENGTH OF THE DELIVERY WIRE.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S032
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2011-02-24
- Decision code
- APPR
- Date received
- 2010-12-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE DUCKBILL VALVE OF THE VALVED INTRODUCER AND CHANGES TO THE LENGTH OF THE DELIVERY WIRE.