PMA P020025S101
- Device
- Blazer (II XP, Prime XP); IntellaTip MiFi XP; IntellaNav XP and IntellaNav MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S101
- Product code
- OAD
- Decision date
- 2017-07-24
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval for packaging changes to the carton, pouch, tray, and luer protector.
Current openFDA PMA Record#
- Device
- Blazer (II XP, Prime XP); IntellaTip MiFi XP; IntellaNav XP and IntellaNav MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S101
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-07-24
- Decision code
- APPR
- Date received
- 2017-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for packaging changes to the carton, pouch, tray, and luer protector.