PMA P950005S072

Device
Celsius Catheter
Applicant
Biosense Webster, Inc.
PMA number
P950005
Supplement
S072
Product code
LPB
Decision date
2019-08-02
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
Alternate supplier for tip electrode components.

Current openFDA PMA Record#

Device
Celsius Catheter
Applicant
Biosense Webster, Inc.
PMA number
P950005
Supplement
S072
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2019-08-02
Decision code
OK30
Date received
2019-07-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier for tip electrode components.