Approval for a change to the pressure sensor thermal offset determination process and a change to align the device lumen patency test sequence.
| Device | AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | AEGEA MEDICAL , INC |
| Date Received | 2018-08-31 |
| Decision Date | 2018-11-29 |
| PMA | P160047 |
| Supplement | S003 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AEGEA MEDICAL , INC 2686 Middlefield Rd Suite A redwood City, CA 94063 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160047 | | Original Filing |
| S028 |
2022-12-21 |
30-day Notice |
| S027 |
2022-11-14 |
30-day Notice |
| S026 |
2022-01-05 |
30-day Notice |
| S025 |
2021-09-28 |
30-day Notice |
| S024 |
2021-04-01 |
30-day Notice |
| S023 |
2021-03-25 |
30-day Notice |
| S022 |
2021-03-23 |
30-day Notice |
| S021 | | |
| S020 |
2021-01-06 |
30-day Notice |
| S019 |
2020-12-22 |
30-day Notice |
| S018 | | |
| S017 |
2020-10-01 |
30-day Notice |
| S016 |
2020-10-01 |
30-day Notice |
| S015 |
2020-09-29 |
30-day Notice |
| S014 |
2020-09-25 |
30-day Notice |
| S013 |
2020-07-06 |
Real-time Process |
| S012 |
2020-06-22 |
30-day Notice |
| S011 |
2020-06-05 |
30-day Notice |
| S010 |
2020-04-07 |
30-day Notice |
| S009 | | |
| S008 | | |
| S007 |
2019-10-10 |
Normal 180 Day Track No User Fee |
| S006 | | |
| S005 | | |
| S004 |
2018-12-18 |
Normal 180 Day Track No User Fee |
| S003 |
2018-08-31 |
Normal 180 Day Track |
| S002 |
2018-08-27 |
30-day Notice |
| S001 |
2018-03-05 |
Normal 180 Day Track |
NIH GUDID Devices