FDA.report

Product code OAE

Current FDA Classification

Device name
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Medical specialty
Unknown
Device class
3
Review panel
CV
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
For the treatment of atrial fibrillation.

Related PMA Records

PMADeviceApplicantDecision date
P150026S007HeartLight Endoscopic Ablation SystemCARDIOFOCUS, INC.2019-11-08
P130026S052TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor EnabledSt. Jude Medical2019-10-25
P130026S053TactiCath Quartz Catheter Contact Force Ablation CatheterSt. Jude Medical2019-10-22
P100010S097Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation CathetersMedtronic CryoCath LP2019-10-18
P130026S051TactiCath Contact Force Ablation Catheter, Sensor EnabledSt. Jude Medical2019-10-09
P100010S096Arctic Front Advance Cardiac CryoAblation CathetersMedtronic CryoCath LP2019-09-19
P130026S050TactiCath Quartz Contact Force Ablation CatheterSt. Jude Medical2019-09-18
P130026S049TACTICATH QUARTZ SETSt. Jude Medical2019-07-24
P100010S093Artic Front Advance Pro Cardiac Cryoablation CatheterMedtronic CryoCath LP2019-06-27
P150026S006HeartLight Endoscopic Ablation SystemCARDIOFOCUS, INC.2019-06-24
P130026S047TactiCath Quartz Contact Force Ablation CatheterSt. Jude Medical2019-06-19
P100010S095Arctic Front Advance Cardiac CryoAblation CathetersMedtronic CryoCath LP2019-06-17
P130026S046TactiSys Quartz SystemSt. Jude Medical2019-06-13
P100010S094Arctic Front Advance Cardiac Cryoablation CathetersMedtronic CryoCath LP2019-06-04
P100010S092Artic Front Advance Cardiac CryoAblation CathetersMedtronic CryoCath LP2019-05-08
P130026S045Tacticath Contact Force Ablation Catheter, Sensor Enabled (Tacticath SE)St. Jude Medical2019-05-07
P100010S091Arctic Front Advance Cardiac CryoAblation CathetersMedtronic CryoCath LP2019-05-03
P100010S086Arctic Front, Front Advance Cardiac Cryoablation, Freezor MAX & CryoConsoleSystemMedtronic CryoCath LP2019-05-01
P130026S044TactiCath Contact Force Ablation Catheter, Sensor EnabledSt. Jude Medical2019-04-23
P130026S043TactiCath Contact Force Ablation Catheter, Sensor EnabledSt. Jude Medical2019-04-10
P150026S005HeartLight Endoscopic Ablation SystemCARDIOFOCUS, INC.2019-04-08
P100010S089Arctic Fron Advance and Arctic Front Advance Pro Cardiac CryoAblation CathetersMedtronic CryoCath LP2019-04-03
P130026S040TactiCath Quartz Contract Force Ablation CatheterSt. Jude Medical2019-03-14
P130026S042TactiCatch Quartz Contact Force Ablation CatheterSt. Jude Medical2019-03-05
P100010S088Arctic Front Advance Cardiac Cryoablation CatheterMedtronic CryoCath LP2019-03-05
P130026S041TactiCath Quartz Contact Force Ablation CatheterSt. Jude Medical2019-02-25
P130026S039TactiCath Contact Force Ablation Catheter, Sensor EnabledSt. Jude Medical2019-02-15
P130026S038TactiCath Contact Force Ablation Catheter, Sensor EnabledSt. Jude Medical2019-02-11
P130026S037TactiCath Quartz SetSt. Jude Medical2019-01-10
P100010S087Arctic Front Advance Pro Cardiac Cryoablation CatheterMedtronic CryoCath LP2019-01-03

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