Hydro Thermablator Endometrial Ablation System
FDA premarket approval P000040/S036 · decided 2017-05-26
Approval details
- PMA number
- P000040
- Supplement
- S036
- 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
- 2017-04-28
- Decision date
- 2017-05-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Updates to the Programmable Logic Controller (PLC) software used for sterilization Chamber 3, an update to the vacuum pump system used in Chamber 3, and an update to the validation documentation structure used to support the system.
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