FDA.reportPublic FDA data

PMA P130026S069

Device
TactiCath Quartz Contact Force Ablation Catheter
Applicant
St Jude Medical
Product code
OAE
Decision date
2021-08-03
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Approval for a labeling update for the TactiCath Quartz Contact Force Ablation Catheter Instructions for Use to included a summary of the long-term effectiveness data from the TactiCath Quartz Post-Approval Study.

Current openFDA PMA Record#

Device
TactiCath Quartz Contact Force Ablation Catheter
Applicant
St Jude Medical
PMA number
P130026
Supplement
S069
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2021-08-03
Decision code
APPR
Date received
2021-02-05
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - PAS
Approval order statement
Approval for a labeling update for the TactiCath Quartz Contact Force Ablation Catheter Instructions for Use to included a summary of the long-term effectiveness data from the TactiCath Quartz Post-Approval Study.