PMA P000032S036
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S036
- Product code
- MNB
- Decision date
- 2011-10-12
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNETICUT.
Current openFDA PMA Record#
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S036
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2011-10-12
- Decision code
- APPR
- Date received
- 2011-07-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOPERSURGICAL, INC. IN TRUMBULL, CONNETICUT.