PMA P230002
- Device
- Minitouch 3.8 Era System (Minitouch System)
- Applicant
- Microcube, LLC
- Product code
- MNB
- Decision date
- 2024-07-16
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for labeling changes that reflect the findings of the completed post-approval study (PAS) for the Minitouch 3.8 Era System (Minitouch System).
Current openFDA PMA Record#
- Device
- Minitouch 3.8 Era System (Minitouch System)
- Applicant
- Microcube, LLC
- PMA number
- P230002
- Supplement
- S001
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2024-07-16
- Decision code
- APPR
- Date received
- 2024-04-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes that reflect the findings of the completed post-approval study (PAS) for the Minitouch 3.8 Era System (Minitouch System).