PMA P970021S040
- Device
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S040
- Product code
- MNB
- Decision date
- 2014-03-17
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A CHANGE TO THE HEATER WIRE SHRINK TUBING WITHIN THE BALLOON.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S040
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2014-03-17
- Decision code
- APPR
- Date received
- 2013-12-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE HEATER WIRE SHRINK TUBING WITHIN THE BALLOON.