- Device
- GYNECARE THERMACHOICE UTERINE BALLON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S041
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2014-04-09
- Decision code
- APPR
- Date received
- 2014-03-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE MANUFACTURING SITE TO BE CHANGED TO CEA MEDICAL MANUFACTURING, INC., IN COLORADO SPRINGS, COLORADO.