PMA P180032S004

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S004
Product code
MNB
Decision date
2021-02-23
Generic name
Device, thermal ablation, endometrial
Approval order statement
Change in facility within the same establishment.

Current openFDA PMA Record#

Device
Cerene Cryotherapy Device
Applicant
Channel Medsystems, Inc.
PMA number
P180032
Supplement
S004
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2021-02-23
Decision code
OK30
Date received
2021-02-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in facility within the same establishment.