PMA P000032S020
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S020
- Product code
- MNB
- Decision date
- 2006-08-15
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A CHANGE IN ADHESIVE FORMULATION USED TO BOND THE THERMOCOUPLE AND HEATER WIRES FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S020
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2006-08-15
- Decision code
- APPR
- Date received
- 2006-05-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN ADHESIVE FORMULATION USED TO BOND THE THERMOCOUPLE AND HEATER WIRES FOR THE DEVICE.