HeartLogic
FDA premarket approval P960040/S493 · decided 2023-11-15
Approval details
- PMA number
- P960040
- Supplement
- S493
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- HeartLogic
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-05-24
- Decision date
- 2023-11-15
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for updated labeling to include information regarding the Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF) Post Approval Study 2 (PAS002) for the HeartLogic feature utilizing real-world data from the Boston Scientific Device Tracking Database (TRaC II), Center for Medicaid and Medicare Services Administrative Claims Database (CMS claims), and the Boston Scientific LATITUDE NXT Patient Management System (LATITUDE System).
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