- Device
- IntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav OI, Blazer OI
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S068
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-12-10
- Decision code
- OK30
- Date received
- 2021-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new piece of equipment at the supplier to automate the current manual process used to decore the braided subassembly.