PMA P020014S009
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S009
- Product code
- HHS
- Decision date
- 2005-07-12
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR MODIFICATION OF DEVICE LABELING TO INCLUDE 4- AND 5-YEAR EFFECTIVENESS RESULTS AND OTHER LABELING CHANGES.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S009
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2005-07-12
- Decision code
- APPR
- Date received
- 2005-01-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION OF DEVICE LABELING TO INCLUDE 4- AND 5-YEAR EFFECTIVENESS RESULTS AND OTHER LABELING CHANGES.