GENESYS HTA SYSTEM
FDA premarket approval P000040/S028 · decided 2013-07-09
Approval details
- PMA number
- P000040
- Supplement
- S028
- 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
- 2013-02-22
- Decision date
- 2013-07-09
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR AN ENERGY DIRECTED WELDING PROCESS FOR THE GENESYS HTA FILTER ASSEMBLY COMPONENTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.