HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
FDA premarket approval P000032/S028 · decided 2009-03-27
Approval details
- PMA number
- P000032
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2008-06-06
- Decision date
- 2009-03-27
- Days to decision
- 294 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- Statement
- APPROVAL FOR A MODIFICATION TO THE LABELING THE HER OPTION TO INCLUDE THE RESULTS OF THE CLINICAL STUDY CONDUCTED TO INVESTIGATE THE SAFETY AND EFFECTIVENESS OF THE EXTENDED TREATMENT REGIMEN (ETR).
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