INTELLATIP MIFI XP TEMPERATURE ABLATION SYSTEM
FDA premarket approval P020025/S088 · decided 2016-07-07
Approval details
- PMA number
- P020025
- Supplement
- S088
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTELLATIP MIFI XP TEMPERATURE ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2016-05-11
- Decision date
- 2016-07-07
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a design change to the thermistor wire insulating material.
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