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.
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.
|Generic Name||Device, Thermal Ablation, Endometrial|
|Applicant||Channel Medsystems, Inc.|
|Supplement Type||Normal 180 Day Track|
|Supplement Reason||Change Design/components/specifications/material|
|Applicant Address||Channel Medsystems, Inc. 5858 Horton Street, Suite 200 emeryville, CA 94608|
|Supplement Number||Date||Supplement Type|
|S001||2020-01-03||Normal 180 Day Track|