- Device
- Blazer OI Catheter, IntellaNav OI Catheter, IntellaNav MiFi OI Catheter, IntellaTip MiFi OI Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S059
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a new proximal shaft inspection step during the manufacturing process