Cerene® Cryotherapy

FDA Premarket Approval P180032 S011

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 NumberS011 Date Received12/21/2022 Decision Date01/17/2023 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-21
Decision Date2023-01-17
PMAP180032
SupplementS011
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 NumberS011 Date Received12/21/2022 Decision Date01/17/2023 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  
Approval For A Modification To The Manufacturing Process To Improve The PCB-to-battery Tray Solder Joint For The Cerene Controller Board.

Supplemental Filings

Supplement NumberDateSupplement Type
P180032Original Filing
S011 2022-12-21 Special (immediate Track)
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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