PMA P150005S047
- Device
- Blazer OI, IntellaNav OI, IntellaTip Mifi OI, and IntellaNav Mifi OI Cardiac Ablation Percutaneous Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S047
- Product code
- OAD
- Decision date
- 2019-08-23
- 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 a material change to the proximal extension tubing of the BSC Open Irrigation Ablation Catheters
Current openFDA PMA Record#
- Device
- Blazer OI, IntellaNav OI, IntellaTip Mifi OI, and IntellaNav Mifi OI Cardiac Ablation Percutaneous Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S047
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-08-23
- Decision code
- APPR
- Date received
- 2019-06-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a material change to the proximal extension tubing of the BSC Open Irrigation Ablation Catheters