PMA P020014S029
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S029
- Product code
- HHS
- Decision date
- 2010-04-06
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR UPDATED MICRO-INSERT PLACEMENT RATES IN THE PHYSICIAN LABELING RESULTING FROM THE ESS305 POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S029
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2010-04-06
- Decision code
- APPR
- Date received
- 2009-10-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATED MICRO-INSERT PLACEMENT RATES IN THE PHYSICIAN LABELING RESULTING FROM THE ESS305 POST-APPROVAL STUDY.