PMA P020014S034
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S034
- Product code
- HHS
- Decision date
- 2011-07-01
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL TO REMOVE A CONTRAINDICATION AND TO REVISE A WARNING REGARDING NICKEL SENSITIVITY IN PHYSICIANS LABELING.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S034
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2011-07-01
- Decision code
- APPR
- Date received
- 2011-04-12
- Approval order statement
- APPROVAL TO REMOVE A CONTRAINDICATION AND TO REVISE A WARNING REGARDING NICKEL SENSITIVITY IN PHYSICIANS LABELING.