PMA P150005S046
- Device
- Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S046
- Product code
- OAD
- Decision date
- 2019-05-23
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Alternative supplier for the Dual Taper Cooling Lumen used in the Open Irrigation (OI) Ablation Catheter families.
Current openFDA PMA Record#
- Device
- Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S046
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-05-23
- Decision code
- OK30
- Date received
- 2019-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative supplier for the Dual Taper Cooling Lumen used in the Open Irrigation (OI) Ablation Catheter families.