PMA P970021S030
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S030
- Product code
- MNB
- Decision date
- 2011-06-13
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR CHANGES TO THE CATHETER BALLOON MEASUREMENT PROCESS.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S030
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2011-06-13
- Decision code
- APPR
- Date received
- 2010-10-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE CATHETER BALLOON MEASUREMENT PROCESS.