GENESYS HTA SYSTEM
FDA premarket approval P000040/S030 · decided 2013-07-19
Approval details
- PMA number
- P000040
- Supplement
- S030
- 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
- 2013-04-10
- Decision date
- 2013-07-19
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR A CHANGE TO THE GOLD THICKNESS SPECIFICATION OF THE CASSETTE CONTACT PINS FROM FLASH GOLD TO >= 15 MICRON-INCHES AND A MODIFICATION TO THE SHIPPER TRAY SO THAT THE CONTACT PINS DO NOT CONTACT ITS LID.
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