PMA P970021S027
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S027
- Product code
- MNB
- Decision date
- 2009-06-19
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- USE OF A NEW SUB-TIER SUPPLIER DURING THE MANUFACTURING OF THE DEVICE.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S027
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2009-06-19
- Decision code
- OK30
- Date received
- 2009-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A NEW SUB-TIER SUPPLIER DURING THE MANUFACTURING OF THE DEVICE.