PMA P970021S025

Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S025
Product code: MNB
Decision date: 2009-02-11
Classification: Device, Thermal Ablation, Endometrial
Generic name: Device, thermal ablation, endometrial
Approval order statement: APPROVAL FOR A MODIFIED TRI-Y, COMPONENT OF THE BALLOON CATHETER, AND A CHANGE TO THE RAW MATERIAL SPECIFICATION FOR THE PRESSURE TUBING.

Current openFDA PMA Record#

Device: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S025
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2009-02-11
Decision code: APPR
Date received: 2008-12-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED TRI-Y, COMPONENT OF THE BALLOON CATHETER, AND A CHANGE TO THE RAW MATERIAL SPECIFICATION FOR THE PRESSURE TUBING.