|
Device | HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | CooperSurgical, Inc. 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | P000032 |
Date Received | 07/27/2000 |
Decision Date | 04/20/2001 |
Withdrawal Date
|
09/07/2023 |
Product Code |
MNB |
Docket Number | 01M-0412 |
Notice Date | 09/24/2001 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HEROPTION(TM) UTERINE CRYOBLATION THERAPY(TM) SYSTEM. THE DEVICE IS A CLOSED-CYCLE CRYOSURGICAL DEVICE INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S003 S004 S005 S006 S008 S009 S011 S012 S013 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 |