PMA P000032S038
- Device
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S038
- Product code
- MNB
- Decision date
- 2013-02-06
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S038
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2013-02-06
- Decision code
- APPR
- Date received
- 2012-08-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR CHANGES TO THE LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY.