Intella Tip MiFi XP cardiac ablation catheters
FDA premarket approval P020025/S098 · decided 2017-06-01
Approval details
- PMA number
- P020025
- Supplement
- S098
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Intella Tip MiFi XP cardiac ablation catheters
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2017-03-29
- Decision date
- 2017-06-01
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for design and associated manufacturing changes to the distal tip of IntellaTip MiFi XP ablation catheters.
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