|
Device | Cerene Cryotherapy Device |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Channel Medsystems, Inc. 5858 Horton Street, Suite 200 Emeryville, CA 94608 |
PMA Number | P180032 |
Supplement Number | S002 |
Date Received | 10/21/2020 |
Decision Date | 11/18/2020 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of labeling changes to improve safety information related to EMC and electrical safety. |