PMA P970021S038
- Device
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S038
- Product code
- MNB
- Decision date
- 2013-06-20
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A CHANGE IN PRESSURE TRANSDUCER.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S038
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2013-06-20
- Decision code
- APPR
- Date received
- 2013-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN PRESSURE TRANSDUCER.