Approval for changes to the specifications of the device including the upper limit of the amount of n2o delivered, the operating temperature range, and the parameter range of initiating a fault, as well as changes to lcd prompts, the venting mechanism, hardware, tray packaging, software, and contractors for sterilizing, packaging, and labeling.
| Device | Cerene Cryotherapy |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Channel Medsystems, Inc. |
| Date Received | 2020-01-03 |
| Decision Date | 2020-07-08 |
| PMA | P180032 |
| Supplement | S001 |
| 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 | Channel Medsystems, Inc. 5858 Horton Street, Suite 200 emeryville, CA 94608 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180032 | | Original Filing |
| S011 |
2022-12-21 |
Special (immediate Track) |
| S010 |
2022-05-02 |
Special (immediate Track) |
| S009 |
2021-08-09 |
30-day Notice |
| S008 |
2021-07-01 |
30-day Notice |
| S007 |
2021-06-30 |
30-day Notice |
| S006 | | |
| S005 |
2021-03-29 |
Special (immediate Track) |
| S004 |
2021-02-01 |
30-day Notice |
| S003 |
2020-10-29 |
Normal 180 Day Track No User Fee |
| S002 |
2020-10-21 |
Special (immediate Track) |
| S001 |
2020-01-03 |
Normal 180 Day Track |
NIH GUDID Devices