PMA P150005S060
- Device
- Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S060
- Product code
- OAD
- Decision date
- 2020-12-15
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- to modify the Cooling Handle Assembly manufacturing process
Current openFDA PMA Record#
- Device
- Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S060
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-12-15
- Decision code
- OK30
- Date received
- 2020-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the Cooling Handle Assembly manufacturing process