PMA P020014S008
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S008
- Product code
- HHS
- Decision date
- 2005-01-31
- Classification
- Transcervical Contraceptive Tubal Occlusion Device
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR A PROPOSED PACKAGING MODIFICATION AND SUBSEQUENT CHANGES TO THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE AND SHELF LIFE VALIDATION STUDY.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S008
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2005-01-31
- Decision code
- APPR
- Date received
- 2004-09-20
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A PROPOSED PACKAGING MODIFICATION AND SUBSEQUENT CHANGES TO THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE AND SHELF LIFE VALIDATION STUDY.