FDA.reportPublic FDA data

PMA P030031S109

Device
THERMOCOOL SMARTTOUCH SF Catheter
Applicant
Biosense Webster, Inc.
Product code
OAD
Decision date
2021-03-26
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
Approval of a revised protocol for the Real-World Experience of Catheter Ablation of Persistent Atrial Fibrillation post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
THERMOCOOL SMARTTOUCH SF Catheter
Applicant
Biosense Webster, Inc.
PMA number
P030031
Supplement
S109
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2021-03-26
Decision code
APPR
Date received
2020-10-30
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of a revised protocol for the Real-World Experience of Catheter Ablation of Persistent Atrial Fibrillation post-approval study (PAS) protocol.