PMA P970021S012
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S012
- Product code
- MKN
- Decision date
- 2005-01-03
- Classification
- Catheter, Balloon, Transcervical
- Generic name
- Catheter, balloon, transcervical
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE, OPERATING MANUAL AND CONTROLLER PULL-OUT CARD.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S012
- Product code
- MKN
- Generic name
- Catheter, balloon, transcervical
- Decision date
- 2005-01-03
- Decision code
- APPR
- Date received
- 2004-12-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE, OPERATING MANUAL AND CONTROLLER PULL-OUT CARD.