PMA P970021S006

Device: THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S006
Product code: MKN
Decision date: 2003-05-07
Classification: Catheter, Balloon, Transcervical
Generic name: Catheter, balloon, transcervical
Approval order statement: APPROVAL FOR A MATERIAL CHANGE TO THE SILIXONE BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM.

Current openFDA PMA Record#

Device: THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S006
Product code: MKN
Generic name: Catheter, balloon, transcervical
Decision date: 2003-05-07
Decision code: APPR
Date received: 2002-11-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MATERIAL CHANGE TO THE SILIXONE BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM.