PMA P000032S012
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S012
- Product code
- MNB
- Decision date
- 2005-09-21
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A CHANGE IN MATERIAL TO THE PRECOOL FINNED TUBING AND THE MIXED GAS FINNED TUBING FROM 304 STAINLESS STEEL TO INCONEL 625
Current openFDA PMA Record#
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S012
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2005-09-21
- Decision code
- APPR
- Date received
- 2005-08-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN MATERIAL TO THE PRECOOL FINNED TUBING AND THE MIXED GAS FINNED TUBING FROM 304 STAINLESS STEEL TO INCONEL 625