PMA P000032S028
- Device
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S028
- Product code
- MNB
- Decision date
- 2009-03-27
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, Thermal Ablation, Endometrial
- Approval order 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).
Current openFDA PMA Record
- Device
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S028
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2009-03-27
- Decision code
- APPR
- Date received
- 2008-06-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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).