PMA P970021S028
- Device
- GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S028
- Product code
- MNB
- Decision date
- 2010-05-13
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR UPDATED PROFESSIONAL LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY REQUIRED AS A CONDITION OF APPROVAL TO SUPPLEMENT 14.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S028
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2010-05-13
- Decision code
- APPR
- Date received
- 2009-11-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR UPDATED PROFESSIONAL LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY REQUIRED AS A CONDITION OF APPROVAL TO SUPPLEMENT 14.