PMA P000032S030
- Device
- HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S030
- Product code
- MNB
- Decision date
- 2010-01-20
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A CHANGE TO THE REFRIGERANT BLEND USED IN THE GAS MIX COMPRESSOR (GMC) OF THE HER OPTION CONSOLE.
Current openFDA PMA Record#
- Device
- HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S030
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2010-01-20
- Decision code
- APPR
- Date received
- 2009-11-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE REFRIGERANT BLEND USED IN THE GAS MIX COMPRESSOR (GMC) OF THE HER OPTION CONSOLE.