PMA P020014S044
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S044
- Product code
- HHS
- Decision date
- 2016-05-12
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- Approval of changes to the post-approval study protocol.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S044
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2016-05-12
- Decision code
- APPR
- Date received
- 2015-09-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of changes to the post-approval study protocol.