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 2025-06-23

Catheter, Balloon, Urethral, Drug-Coated

Applicant Urotronic, Inc.

PMA Number P210020

Class 3

View Details →

PMA 2025-06-20

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase

Applicant Ventana Medical Systems, Inc.

PMA Number P140025

Class 3

View Details →

PMA 2025-06-20

Immunohistochemistry antibody assay, c-kit

Applicant Ventana Medical Systems, Inc.

PMA Number P020055

Class 3

View Details →

PMA 2025-06-20

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Ceramtec GmbH

PMA Number P010001

Class 3

View Details →

PMA 2025-06-20

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Ventana Medical Systems, Inc.

PMA Number P160046

Class 3

View Details →

PMA 2025-06-20

Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief

Applicant Mainstay Medical Limited

PMA Number P190021

Class 3

View Details →

PMA 2025-06-20

Immunohistochemistry Assay, Antibody, FOLR1

Applicant Ventana Medical Systems, Inc.

PMA Number P220006

Class 3

View Details →

PMA 2025-06-20

Immunohistochemistry assay, antibody, claudin 18

Applicant Ventana Medical Systems, Inc.

PMA Number P230018

Class 3

View Details →

PMA 2025-06-18

Pump, infusion, implanted, programmable

Applicant Infusyn Therapeutics, LLC

PMA Number P080012

Class 3

View Details →

PMA 2025-06-16

P2psa

Applicant Beckman Coulter, Inc.

PMA Number P090026

Class 3

View Details →

PMA 2025-06-06

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Surmodics,Inc.

PMA Number P210025

Class 3

View Details →

PMA 2025-06-05

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic, Inc.

PMA Number P090013

Class 3

View Details →

Page 50 of 80

↑