Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceCerene Cryotherapy Device
Generic NameDevice, thermal ablation, endometrial
ApplicantChannel Medsystems, Inc.
5858 Horton St., Suite 200
Emeryville, CA 94608
PMA NumberP180032
Supplement NumberS020
Date Received09/19/2024
Decision Date12/12/2024
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the change to sterilization methods to allow the Cerene Cryotherapy Device to be sterilized up to two times with ethylene oxide (2X EO).
-
-