GENESYS HTA SYSTEM
FDA premarket approval P000040/S034 · decided 2014-11-25
Approval details
- PMA number
- P000040
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2014-10-27
- Decision date
- 2014-11-25
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- REMOVAL OF THE IN-PROCESS BURST TEST FOR THE SHEATH ASSEMBLY TRAY.
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