PMA P020014S030
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S030
- Product code
- HHS
- Decision date
- 2010-02-15
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- MODIFICATION OF THE RAW MATERIAL IN THE PACKAGING POUCH OF THE ESSURE® SYSTEM.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S030
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2010-02-15
- Decision code
- OK30
- Date received
- 2010-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF THE RAW MATERIAL IN THE PACKAGING POUCH OF THE ESSURE® SYSTEM.