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 NumberS010 Date Received05/02/2022 Decision Date05/31/2022 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 | 2022-05-02 |
| Decision Date | 2022-05-31 |
| PMA | P180032 |
| Supplement | S010 |
| 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 NumberS010 Date Received05/02/2022 Decision Date05/31/2022 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 Modification To The Manufacturing Process For The Subject Device. This Change Is The Addition Of An Inspection Step Made To The Manufacturing Process To Verify That The Control Software Has Been Successfully Loaded Onto The Device. |
| 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 |