FDA.reportPublic FDA data

PMA P950005S074

Device
Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St
Applicant
Biosense Webster, Inc.
PMA number
P950005
Supplement
S074
Product code
LPB
Decision date
2020-04-16
Generic name
Cardiac ablation percutaneous catheter
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 Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St
Applicant
Biosense Webster, Inc.
PMA number
P950005
Supplement
S074
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
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.