PMA P020014S049
- Device
- Essure System for Permanent Birth Control
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S049
- Product code
- HHS
- Decision date
- 2017-12-04
- Classification
- Transcervical Contraceptive Tubal Occlusion Device
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- Change in a supplier's site of manufacture of the wound coil, inner coil and outer coil critical components from Tualatin Oregon to Heredia, Costa Rica.
Current openFDA PMA Record#
- Device
- Essure System for Permanent Birth Control
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S049
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2017-12-04
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in a supplier's site of manufacture of the wound coil, inner coil and outer coil critical components from Tualatin Oregon to Heredia, Costa Rica.