AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
FDA premarket approval P160047/S003 · decided 2018-11-29
Approval details
- PMA number
- P160047
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2018-08-31
- Decision date
- 2018-11-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- Approval for a change to the Pressure Sensor thermal offset determination process and a change to align the Device Lumen Patency Test sequence.
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