PMA P020014S025
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S025
- Product code
- HHS
- Decision date
- 2009-06-11
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- CHANGE TO THE MANUFACTURING OF THE MECHANISM THAT HOLDS THE INNER CATHETER SUBASSEMBLY RELEASE RIBBON IN PLACE.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S025
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2009-06-11
- Decision code
- OK30
- Date received
- 2009-05-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURING OF THE MECHANISM THAT HOLDS THE INNER CATHETER SUBASSEMBLY RELEASE RIBBON IN PLACE.