PMA P000032
- Device
- Her Option Office Cryoablation Therapy System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S043
- Product code
- MNB
- Decision date
- 2018-07-11
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for changes to device materials included in the Disposable Probe of the Her Option® Office Cryoablation Therapy System.
Current openFDA PMA Record#
- Device
- Her Option Office Cryoablation Therapy System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S043
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2018-07-11
- Decision code
- APPR
- Date received
- 2017-12-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to device materials included in the Disposable Probe of the Her Option® Office Cryoablation Therapy System.