IntellaNav XP, Nav MiFi XP
FDA premarket approval P020025/S096 · decided 2017-05-08
Approval details
- PMA number
- P020025
- Supplement
- S096
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IntellaNav XP, Nav MiFi XP
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2017-03-03
- Decision date
- 2017-05-08
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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