PMA P970021S019
- Device
- GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S019
- Product code
- MNB
- Decision date
- 2008-05-23
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A MODIFICATION IN THE ETHYLENE OXIDE STERILIZATION PROCESS TO ACCOMMODATE A MINIMUM LOAD CAPACITY OF ONE PALLET.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S019
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2008-05-23
- Decision code
- APPR
- Date received
- 2008-04-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION IN THE ETHYLENE OXIDE STERILIZATION PROCESS TO ACCOMMODATE A MINIMUM LOAD CAPACITY OF ONE PALLET.