HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
FDA premarket approval P000032 · decided 2001-04-20
Approval details
- PMA number
- P000032
- Trade name
- HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2000-07-27
- Decision date
- 2001-04-20
- Days to decision
- 267 days
- Decision code
- APWD
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- 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.
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