PMA P020025S096
- Device
- IntellaNav XP, Nav MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S096
- Product code
- OAD
- Decision date
- 2017-05-08
- 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 to change the ablation connection box design, IntellaNav Ablation Connection Box, to the Rhythmia HDx Ablation Connection Box, for the family of IntellaNav Ablation Catheters.
Current openFDA PMA Record#
- Device
- IntellaNav XP, Nav MiFi XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S096
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-05-08
- Decision code
- APPR
- Date received
- 2017-03-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to change the ablation connection box design, IntellaNav Ablation Connection Box, to the Rhythmia HDx Ablation Connection Box, for the family of IntellaNav Ablation Catheters.