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PMA P180032S013

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S013
Product code
MNB
Decision date
2023-07-17
Classification
Obstetrics/Gynecology
Generic name
Device, thermal ablation, endometrial
Approval order statement
Modification to the manufacturing process for the subject device. This change is the implementation of updated manufacturing software and associated fixtures that automate some existing manual processes.

Current openFDA PMA Record#

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S013
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2023-07-17
Decision code
OK30
Date received
2023-06-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the manufacturing process for the subject device. This change is the implementation of updated manufacturing software and associated fixtures that automate some existing manual processes.