- Device
- Blazer Open Irrigated Catheter, IntellNav MiFi OI Catheter, IntellaNav OI Catheter, and IntellaTip MiFi OI Catheter, Ste
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S070
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2022-02-25
- Decision code
- OK30
- Date received
- 2022-01-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of parametric release for the BSC2000-2 Ethylene Oxide Sterilization Cycle at the BSC Coventry, RI Facility.