PMA P970021S033
- Device
- GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S033
- Product code
- MNB
- Decision date
- 2011-02-25
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- CHANGE IN THE CLEANING SOLUTION USED IN REMOVING RESIDUE FROM THE HEATING WIRE DURING THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S033
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2011-02-25
- Decision code
- OK30
- Date received
- 2011-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE CLEANING SOLUTION USED IN REMOVING RESIDUE FROM THE HEATING WIRE DURING THE MANUFACTURING PROCESS.