FDA.reportPublic FDA data

PMA P180032S001

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S001
Product code
MNB
Decision date
2020-07-08
Generic name
Device, thermal ablation, endometrial
Approval order statement
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.

Current openFDA PMA Record#

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S001
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2020-07-08
Decision code
APPR
Date received
2020-01-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
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.