PMA P970021S024
- Device
- GYNECARE THERMACHOICE II
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S024
- Product code
- MNB
- Decision date
- 2009-01-14
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- ADDITION OF A DUPLICATE QUALITY CONTROL TEST AND AN AUTOMATED TOOL USED IN THE MANUFACTURING PROCESS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE II
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S024
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2009-01-14
- Decision code
- OK30
- Date received
- 2008-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A DUPLICATE QUALITY CONTROL TEST AND AN AUTOMATED TOOL USED IN THE MANUFACTURING PROCESS FOR THE DEVICE.