Minitouch 3.8 Era System (Minitouch System)
FDA premarket approval P230002/S001 · decided 2024-07-16
Approval details
- PMA number
- P230002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Minitouch 3.8 Era System (Minitouch System)
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Microcube, LLC
- Date received
- 2024-04-25
- Decision date
- 2024-07-16
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Fremont, CA
- 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).
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