FDA.reportPublic FDA data

PMA P010068S059

Device
Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens
Applicant
Biosense Webster, Inc.
PMA number
P010068
Supplement
S059
Product code
OAD
Decision date
2020-04-16
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
Introduce a new ballast spacer material and increased maximum load capacity to be used in the sterilization of Biosense Webster ablation catheters and cables.

Current openFDA PMA Record#

Device
Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens
Applicant
Biosense Webster, Inc.
PMA number
P010068
Supplement
S059
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2020-04-16
Decision code
OK30
Date received
2020-03-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduce a new ballast spacer material and increased maximum load capacity to be used in the sterilization of Biosense Webster ablation catheters and cables.