PMA P970021S009
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S009
- Product code
- MKN
- Decision date
- 2003-12-22
- Classification
- Catheter, Balloon, Transcervical
- Generic name
- Catheter, balloon, transcervical
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE PRESSURE RELIEF VALVE (PRV).
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S009
- Product code
- MKN
- Generic name
- Catheter, balloon, transcervical
- Decision date
- 2003-12-22
- Decision code
- APPR
- Date received
- 2003-06-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE PRESSURE RELIEF VALVE (PRV).