PMA P020014S012
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S012
- Product code
- HHS
- Decision date
- 2007-06-15
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR DESIGN AND MATERIAL CHANGES TO THE MICRO-INSERT, DELIVERY CATHETER, AND INTRODUCER OF THE ESSURE SYSTEM.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S012
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2007-06-15
- Decision code
- APPR
- Date received
- 2006-03-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN AND MATERIAL CHANGES TO THE MICRO-INSERT, DELIVERY CATHETER, AND INTRODUCER OF THE ESSURE SYSTEM.