PMA P030031S118

Device: THERMOCOOL SMARTTOUCH SF Catheter
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S118
Product code: OAD
Decision date: 2021-05-13
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Approval of an updated and finalized protocol for the Real-World Experience of Catheter Ablation of Persistent Atrial Fibrillation post-approval study (PAS)

Current openFDA PMA Record#

Device: THERMOCOOL SMARTTOUCH SF Catheter
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S118
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2021-05-13
Decision code: APPR
Date received: 2021-04-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of an updated and finalized protocol for the Real-World Experience of Catheter Ablation of Persistent Atrial Fibrillation post-approval study (PAS)