Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA Approvals

Premarket Approval devices tracked by MedTracker

PMA 2026-08-03

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant Exact Sciences Corporation

PMA Number P230043

Class 3

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PMA 2026-07-31

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P980035

Class 3

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PMA 2026-07-31

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic, Inc.

PMA Number P010015

Class 3

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PMA 2026-07-31

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P890003

Class 3

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PMA 2026-07-31

Prosthesis, ankle, uncemented, non-constrained

Applicant Dt Medtech, LLC

PMA Number P160036

Class 3

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PMA 2026-07-31

Tympanostomy tube delivery product with drug

Applicant Tusker Medical, Inc.

PMA Number P190016

Class 3

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PMA 2026-07-31

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

PMA Number P200041

Class 3

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PMA 2026-07-31

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic, Inc.

PMA Number P220012

Class 3

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PMA 2026-07-31

Cardiac ablation percutaneous catheter

Applicant Stereotaxis, Inc.

PMA Number P240014

Class 3

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PMA 2026-07-30

Automated external defibrillators (non-wearable)

Applicant Physio-Control, Inc.

PMA Number P170018

Class 3

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PMA 2026-07-30

Stimulator, hypoglossal nerve, implanted, apnea

Applicant Nyxoah S.A.

PMA Number P240024

Class 3

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PMA 2026-07-30

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Personal Genome Diagnostics, Inc.

PMA Number P250036

Class 3

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