PMA P970021S007

Device: GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S007
Product code: MKN
Decision date: 2003-03-27
Classification: Catheter, Balloon, Transcervical
Generic name: Catheter, balloon, transcervical
Approval order statement: APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO. THE GYNECARE THERMACHOICE CONTROLLER WILL BE MANUFACTURED AT THIS FACILITY.

Current openFDA PMA Record#

Device: GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant: Gynecare, Inc.
PMA number: P970021
Supplement: S007
Product code: MKN
Generic name: Catheter, balloon, transcervical
Decision date: 2003-03-27
Decision code: APPR
Date received: 2003-01-13
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO. THE GYNECARE THERMACHOICE CONTROLLER WILL BE MANUFACTURED AT THIS FACILITY.