Hydro Thermablator Endometrial Ablation System
FDA premarket approval P000040/S040 · decided 2020-12-17
Approval details
- PMA number
- P000040
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hydro Thermablator Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2020-12-03
- Decision date
- 2020-12-17
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- updates to the software for sterilization aeration at the BSC Coventry, Rhode Island facility
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