PMA P110016S003
- Device
- THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S003
- Product code
- OAD
- Decision date
- 2013-07-30
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- APPROVAL FOR ADDING A MEDIGUIDE TECHNOLOGY PASSIVE SENSOR INTO THE TIP OF THE DEVICE FOR THE PURPOSES OF AIDING NAVIGATION AND CHANGING THE COOL PATH DUO UNI-DIRECTIONAL (UNI-D) HANDLE TO A COOL PATH DUO BI-DIRECTIONAL (BI-D) HANDLE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COOL PATH DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND SAFIRE DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE CATHETERS ARE INTENDED FOR USE WITH A COMPATIBLE EXTERNAL PUMP AND THE IBI-1500T9-CP RF GENERATOR AT A MAXIMUM OF 50 WATTS. MEDIGUIDE ENABLED ABLATION CATHETERS ARE USED WITH THE MEDIGUIDE TECHNOLOGY TO ENABLE REAL-TIME TIP POSITIONING AND NAVIGATION. THE MEDIGUIDE TECHNOLOGY IS INDICATED FOR USE AS AN ADJUNCT TO FLUOROSCOPY.
Current openFDA PMA Record#
- Device
- THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S003
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2013-07-30
- Decision code
- APPR
- Date received
- 2012-06-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDING A MEDIGUIDE TECHNOLOGY PASSIVE SENSOR INTO THE TIP OF THE DEVICE FOR THE PURPOSES OF AIDING NAVIGATION AND CHANGING THE COOL PATH DUO UNI-DIRECTIONAL (UNI-D) HANDLE TO A COOL PATH DUO BI-DIRECTIONAL (BI-D) HANDLE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COOL PATH DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND SAFIRE DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE CATHETERS ARE INTENDED FOR USE WITH A COMPATIBLE EXTERNAL PUMP AND THE IBI-1500T9-CP RF GENERATOR AT A MAXIMUM OF 50 WATTS. MEDIGUIDE ENABLED ABLATION CATHETERS ARE USED WITH THE MEDIGUIDE TECHNOLOGY TO ENABLE REAL-TIME TIP POSITIONING AND NAVIGATION. THE MEDIGUIDE TECHNOLOGY IS INDICATED FOR USE AS AN ADJUNCT TO FLUOROSCOPY.