- Device
- IntellaTip MiFi XP, IntellaNav MiFi XP and IntellaNav XP Temperature Ablation Catheters
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S125
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-02-19
- Decision code
- OK30
- Date received
- 2020-01-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updating weld process parameters to harmonize across multiple ablation catheter families.