IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch
FDA premarket approval P020025/S132 · decided 2021-08-17
Approval details
- PMA number
- P020025
- Supplement
- S132
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2021-05-19
- Decision date
- 2021-08-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for updated labeling, including modified warnings and directions for use.
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