PMA P020014S035
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S035
- Product code
- HHS
- Decision date
- 2012-03-19
- Classification
- Transcervical Contraceptive Tubal Occlusion Device
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR REVISED PROFESSIONAL AND PATIENT LABELING.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S035
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2012-03-19
- Decision code
- APPR
- Date received
- 2011-04-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED PROFESSIONAL AND PATIENT LABELING.