FDA.reportPublic FDA data

PMA P970021S005

Device
THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant
Gynecare, Inc.
PMA number
P970021
Supplement
S005
Product code
MNB
Decision date
2001-10-19
Classification
Device, Thermal Ablation, Endometrial
Generic name
Device, thermal ablation, endometrial
Approval order statement
APPROVAL TO RELOCATE DEVICE MANUFACTURING DUE TO THE CLOSURE OF THE GYNECARE MENLO PARK FACILITY. MANUFACTURING WILL BE PERFORMED AT RELA/COLORADO MEDTECH, INC, LONGMONT, COLORADO AND AT ETHICON, INC., SOMERVILE, NEW JERSEY.

Current openFDA PMA Record#

Device
THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Applicant
Gynecare, Inc.
PMA number
P970021
Supplement
S005
Product code
MNB
Generic name
Device, thermal ablation, endometrial
Decision date
2001-10-19
Decision code
APPR
Date received
2000-08-28
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL TO RELOCATE DEVICE MANUFACTURING DUE TO THE CLOSURE OF THE GYNECARE MENLO PARK FACILITY. MANUFACTURING WILL BE PERFORMED AT RELA/COLORADO MEDTECH, INC, LONGMONT, COLORADO AND AT ETHICON, INC., SOMERVILE, NEW JERSEY.