PMA P020014S045
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S045
- Product code
- HHS
- Decision date
- 2016-04-28
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- Approval for modifications to the post-approval study protocol.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S045
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2016-04-28
- Decision code
- APPR
- Date received
- 2016-02-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for modifications to the post-approval study protocol.