FDA.reportPublic FDA data

PMA P030031S111

Device
ThermoCool SmartTouch Catheters
Applicant
Biosense Webster, Inc.
PMA number
P030031
Supplement
S111
Product code
OAD
Decision date
2021-01-22
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
Transfer the extrusion process for the Quad Lumen Core subcomponent from the Biosense Webster Inc. Irwindale, CA facility to the Biosense Webster, Inc. Juarez, MX facility.

Current openFDA PMA Record#

Device
ThermoCool SmartTouch Catheters
Applicant
Biosense Webster, Inc.
PMA number
P030031
Supplement
S111
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2021-01-22
Decision code
OK30
Date received
2021-01-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer the extrusion process for the Quad Lumen Core subcomponent from the Biosense Webster Inc. Irwindale, CA facility to the Biosense Webster, Inc. Juarez, MX facility.