|
Device | Cerene® Cryotherapy Device |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Channel Medsystems, Inc. 5858 Horton Street, Suite 200 Emeryville, CA 94608 |
PMA Number | P180032 |
Supplement Number | S005 |
Date Received | 03/29/2021 |
Decision Date | 04/27/2021 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of additional adverse event information and clarification of troubleshooting instructions to the labeling of the instructions for use (IFU-3243 Rev E). |