PMA P970021S015
- Device
- GYNECARETHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S015
- Product code
- MNB
- Decision date
- 2007-11-05
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A CHANGE IN THE ETHYLENE OXIDE STERILIZATION CYCLE.
Current openFDA PMA Record#
- Device
- GYNECARETHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S015
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2007-11-05
- Decision code
- APPR
- Date received
- 2007-07-13
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE ETHYLENE OXIDE STERILIZATION CYCLE.