PMA P970021S008
- Device
- GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S008
- Product code
- MKN
- Decision date
- 2003-07-14
- Classification
- Catheter, Balloon, Transcervical
- Generic name
- Catheter, balloon, transcervical
- Approval order statement
- APPROVAL FOR MODIFIED LABELING FOR THE THERMACHOICE II.
Current openFDA PMA Record#
- Device
- GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM
- Applicant
- Gynecare, Inc.
- PMA number
- P970021
- Supplement
- S008
- Product code
- MKN
- Generic name
- Catheter, balloon, transcervical
- Decision date
- 2003-07-14
- Decision code
- APPR
- Date received
- 2003-01-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFIED LABELING FOR THE THERMACHOICE II.