PMA P020014S033
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S033
- Product code
- HHS
- Decision date
- 2012-02-22
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR AN ALTERNATE HYDROPHILIC COATING OF THE DELIVERY CATHETER.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S033
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2012-02-22
- Decision code
- APPR
- Date received
- 2011-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE HYDROPHILIC COATING OF THE DELIVERY CATHETER.