GENESYS HTA SYSTEM
FDA premarket approval P000040/S026 · decided 2013-01-11
Approval details
- PMA number
- P000040
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2012-10-17
- Decision date
- 2013-01-11
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL TO REPLACE OBSOLETE COMPONENTS IN THE CONTROL UNIT AND MAKE CHANGES TO OTHER COMPONENTS TO ACCOMMODATE THESE NEW PARTS.
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