PMA P970021S014
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S014
- Product code
- MNB
- Decision date
- 2007-07-06
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR REVISED PROFESSIONAL LABELING TO INCLUDE THE RESULTS OF A MULTI-CENTER STUDY OF THE GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY (UBT) SYSTEM.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S014
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2007-07-06
- Decision code
- APPR
- Date received
- 2007-01-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR REVISED PROFESSIONAL LABELING TO INCLUDE THE RESULTS OF A MULTI-CENTER STUDY OF THE GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY (UBT) SYSTEM.