PMA P020025S067
- Device
- BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S067
- Product code
- OAD
- Decision date
- 2015-04-06
- 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 A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.
Current openFDA PMA Record#
- Device
- BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S067
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-04-06
- Decision code
- APPR
- Date received
- 2015-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.