PMA P150005S008
- Device
- INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S008
- Product code
- OAD
- Decision date
- 2017-03-02
- 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 design changes to incorporate three mini electrodes into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaTip MiFi Open-Irrigated Ablation Catheter and is indicated for: The IntellaTip MiFi Open-Irrigated Ablation Catheter, when used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL) in patients age 18 or older.
Current openFDA PMA Record#
- Device
- INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S008
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-03-02
- Decision code
- APPR
- Date received
- 2016-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to incorporate three mini electrodes into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaTip MiFi Open-Irrigated Ablation Catheter and is indicated for: The IntellaTip MiFi Open-Irrigated Ablation Catheter, when used with a Maestro 4000 Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent Type I Atrial Flutter (AFL) in patients age 18 or older.