PMA P970021S039
- Device
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S039
- Product code
- MNB
- Decision date
- 2014-02-24
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS CORPORATION IN BUFFALO GROVE, ILLINOIS.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S039
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2014-02-24
- Decision code
- APPR
- Date received
- 2013-12-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS CORPORATION IN BUFFALO GROVE, ILLINOIS.