Product Code: OAD


Products Classified as OAD

1062Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Total Product Life Cycle (TPLC) Devices

1062Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Pre-market Approvals for OAD

P950005CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONALBiosense Webster, Inc
P150005MetriQ PumpBoston Scientific Corp.
P020025Maestro 4000 ControllerBOSTON SCIENTIFIC
P010068Celsius DS Electrophysiology CatheterBIOSENSE WEBSTER, INC.
P040042Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF GeneratorsIRVINE BIOMEDICAL,INC.(IBI)
P060019Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF GeneratorsIRVINE BIOMEDICAL, INC.
P110016Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy CSt. Jude Medical, Inc. (Irvine Biomedical)
P030031Navistar RMT Thermocool Catheter; Celsius Thermocool Catheter; Celsius RMT Thermocool CatheterBIOSENSE WEBSTER, INC.

Global Unique Device Identification Database

05415067024916catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020093catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020086catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020079catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020062catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020055catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020048catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020031catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067020024catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067019875catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067011510catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067011503catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067011497catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067011152catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
05415067011145catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Maude Adverse Events

INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-31
FLEXABILITY ABLATION CATHETER-UNKNOWNST. JUDE MEDICAL2020-03-31
FLEXABILITY? ABLATION CATHETER, SENSOR ENABLED? CATHETERST. JUDE MEDICAL2020-03-27
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-26
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-26
NAVISTAR? RMT THERMOCOOL? ELECTROPHYSIOLOGY CATHETERBIOSENSE WEBSTER INC2020-03-26
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-25
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-25
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-24
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-24
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-24
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-24
INTELLATIP MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-24
INTELLANAV OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-23
FLEXABILITY?ABLATION CATHETER, UNI-D, CURVE DST. JUDE MEDICAL2020-03-19
UNK_SMART TOUCH BIDIRECTIONALBIOSENSE WEBSTER INC2020-03-17
UNK_SMART TOUCH BIDIRECTIONAL SFBIOSENSE WEBSTER INC2020-03-17
UNK_SMART TOUCH BIDIRECTIONAL SFBIOSENSE WEBSTER INC2020-03-17
UNK_THERMOCOOL SF NAVBIOSENSE WEBSTER INC2020-03-16
UNK_THERMOCOOL SF NAVBIOSENSE WEBSTER INC2020-03-16
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-13
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-13
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-12
BLAZER II XPBOSTON SCIENTIFIC CORPORATION2020-03-12
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-12
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-11
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-11
INTELLANAV OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-11
FLEXABILITY ABLATION CATHETER-UNKNOWNST. JUDE MEDICAL2020-03-10
THERAPY? COOL PATH? DUO ABLATION CATHETERST. JUDE MEDICAL, INC.2020-03-10
FLEXABILITY ABLATION CATHETER-UNKNOWNST. JUDE MEDICAL2020-03-10
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-10
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-10
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-10
INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-06
FLEXABILITY? ABLATION CATHETER, BI-D, CURVE D-FST. JUDE MEDICAL2020-03-05
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-05
INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-03
INTELLANAV MIFI OPEN-IRRIGATEDBOSTON SCIENTIFIC CORPORATION2020-03-03
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-03-03
COOL PATH? IRRIGATED ABLATION CATHETERST. JUDE MEDICAL, INC.2020-03-03
COOL POINT TUBING SETIRVINE BIOMEDICAL, INC.2020-03-02
ST JUDE COOL POINT TUBINGIRVINE BIOMEDICAL, INC.2020-03-02
NAVI-STAR? THERMO-COOL? ELECTROPHYSIOLOGY CATHETERBIOSENSE WEBSTER INC2020-03-02
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-02-26
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-02-26
INTELLANAV MIFI XPBOSTON SCIENTIFIC CORPORATION2020-02-25
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-02-25
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERBOSTON SCIENTIFIC CORPORATION2020-02-22
FLEXABILITY? ABLATION CATHETER, SENSOR ENABLED?ST. JUDE MEDICAL2020-02-21
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