Cerene Cryotherapy

FDA Premarket Approval P180032 S010

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.

Pre-market Approval Supplement Details

DeviceCerene Cryotherapy
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantChannel Medsystems, Inc.5858 Horton Street, Suite 200emeryville, CA 94608 PMA NumberP180032 Supplement NumberS010 Date Received05/02/2022 Decision Date05/31/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-02
Decision Date2022-05-31
PMAP180032
SupplementS010
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressChannel Medsystems, Inc.
5858 Horton Street, Suite 200
emeryville, CA 94608 PMA NumberP180032 Supplement NumberS010 Date Received05/02/2022 Decision Date05/31/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Modification To The Manufacturing Process For The Subject Device. This Change Is The Addition Of An Inspection Step Made To The Manufacturing Process To Verify That The Control Software Has Been Successfully Loaded Onto The Device.

Supplemental Filings

Supplement NumberDateSupplement Type
P180032Original Filing
S010 2022-05-02 Special (immediate Track)
S009 2021-08-09 30-day Notice
S008 2021-07-01 30-day Notice
S007 2021-06-30 30-day Notice
S006
S005 2021-03-29 Special (immediate Track)
S004 2021-02-01 30-day Notice
S003 2020-10-29 Normal 180 Day Track No User Fee
S002 2020-10-21 Special (immediate Track)
S001 2020-01-03 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00850008595035 P180032 001
20850008595022 P180032 001

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