FDA.reportPublic FDA data

PMA P990025S059

Device
EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S059
Product code
DRF
Decision date
2020-04-16
Generic name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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
EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables
Applicant
Biosense Webster, Inc.
PMA number
P990025
Supplement
S059
Product code
DRF
Generic name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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.