PMA P160047S002
- Device
- AEGEA Vapor System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S002
- Product code
- MNB
- Decision date
- 2018-09-25
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Change of manufacturing site where the raw materials are purchased, received, inspected, and stored.
Current openFDA PMA Record#
- Device
- AEGEA Vapor System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S002
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2018-09-25
- Decision code
- OK30
- Date received
- 2018-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of manufacturing site where the raw materials are purchased, received, inspected, and stored.