PMA P000032S003
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S003
- Product code
- MNB
- Decision date
- 2003-08-08
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR EARLY TERMINATION OF THE CLINICAL TECHNIQUE STANDARDIZATION POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S003
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2003-08-08
- Decision code
- APPR
- Date received
- 2003-04-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR EARLY TERMINATION OF THE CLINICAL TECHNIQUE STANDARDIZATION POST-APPROVAL STUDY.