IntellaNav XP and MiFI XP
FDA premarket approval P020025/S115 · decided 2019-01-09
Approval details
- PMA number
- P020025
- Supplement
- S115
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IntellaNav XP and MiFI XP
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2018-10-25
- Decision date
- 2019-01-09
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of manufacturing changes, specifically, the addition of BSC Heredia as an alternate supplier for the Steering Control Wire Subassembly.
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