PMA P180032S019

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S019
Product code
MNB
Decision date
2024-11-22
Classification
Obstetrics/Gynecology
Generic name
Device, thermal ablation, endometrial
Approval order statement
Approval for a change to the design of the Cerene Controller Board.

Current openFDA PMA Record#

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S019
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2024-11-22
Decision code
APPR
Date received
2024-08-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the design of the Cerene Controller Board.