PMA P000032S013
- Device
- HER OPTION CYROABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S013
- Product code
- MNB
- Decision date
- 2006-07-03
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR: 1) UPDATES TO THE SOFTWARE, I.E., IN-ICE DETECTION; 2) IMPROVEMENT IN THE LOCKING TABS; AND 3) LABELING CHANGES.
Current openFDA PMA Record#
- Device
- HER OPTION CYROABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S013
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2006-07-03
- Decision code
- APPR
- Date received
- 2005-08-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) UPDATES TO THE SOFTWARE, I.E., IN-ICE DETECTION; 2) IMPROVEMENT IN THE LOCKING TABS; AND 3) LABELING CHANGES.