PMA P020025S098
- Device
- Intella Tip MiFi XP cardiac ablation catheters
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S098
- Product code
- OAD
- Decision date
- 2017-06-01
- 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 and associated manufacturing changes to the distal tip of IntellaTip MiFi XP ablation catheters.
Current openFDA PMA Record#
- Device
- Intella Tip MiFi XP cardiac ablation catheters
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S098
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-06-01
- Decision code
- APPR
- Date received
- 2017-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and associated manufacturing changes to the distal tip of IntellaTip MiFi XP ablation catheters.