PMA P020025S120
- Device
- Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S120
- Product code
- OAD
- Decision date
- 2019-06-17
- 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 minor design change to the tensioning mechanism for its temperature and open-irrigated cardiac ablation catheters.
Current openFDA PMA Record#
- Device
- Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S120
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-06-17
- Decision code
- APPR
- Date received
- 2019-04-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a minor design change to the tensioning mechanism for its temperature and open-irrigated cardiac ablation catheters.