PMA P000032S027
- Device
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S027
- Product code
- MNB
- Decision date
- 2008-05-30
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.
Current openFDA PMA Record#
- Device
- HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S027
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2008-05-30
- Decision code
- OK30
- Date received
- 2008-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CONVERSION OF A PART OF THE PRODUCTION SYSTEM FROM A MANUAL TO A SOFTWARE AUTOMATED OPERATION.