GENESYS HTA SYSTEM
FDA premarket approval P000040/S029 · decided 2013-08-14
Approval details
- PMA number
- P000040
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2013-02-22
- Decision date
- 2013-08-14
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR UPDATED LABELING TO REFLECT THE RESULTS OF THE GENESYS HTA SYSTEM POST-APPROVAL STUDY PROTOCOL.
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