This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Cerene® Cryotherapy |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Channel Medsystems, Inc.5858 Horton Street, Suite 200emeryville, CA 94608 PMA NumberP180032 Supplement NumberS011 Date Received12/21/2022 Decision Date01/17/2023 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-21 |
| Decision Date | 2023-01-17 |
| PMA | P180032 |
| Supplement | S011 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Channel Medsystems, Inc. 5858 Horton Street, Suite 200 emeryville, CA 94608 PMA NumberP180032 Supplement NumberS011 Date Received12/21/2022 Decision Date01/17/2023 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For A Modification To The Manufacturing Process To Improve The PCB-to-battery Tray Solder Joint For The Cerene Controller Board. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00850008595035 | P180032 | 001 |
| 20850008595022 | P180032 | 001 |
| 00850008595042 | P180032 | 001 |