PMA P160047S020
- Device
- Mara Water Vapor Probe
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S020
- Product code
- MNB
- Decision date
- 2021-01-27
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Changes to the sheath material source and the sheath bonding process.
Current openFDA PMA Record#
- Device
- Mara Water Vapor Probe
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S020
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-01-27
- Decision code
- OK30
- Date received
- 2021-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the sheath material source and the sheath bonding process.