INTELLANAV MIFI XP; INTELLATIP MIFI XP
FDA premarket approval P020025/S091 · decided 2016-12-13
Approval details
- PMA number
- P020025
- Supplement
- S091
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTELLANAV MIFI XP; INTELLATIP MIFI XP
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2016-09-01
- Decision date
- 2016-12-13
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of an alternate supplier for the mini-electrode components.
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