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 2026-09-14

Prosthesis, penis, inflatable

Applicant Boston Scientific Corp

PMA Number N970012

Class 3

View Details →

PMA 2026-09-14

Stimulator, electrical, implantable, for incontinence

Applicant Medtronic Neuromodulation

PMA Number P970004

Class 3

View Details →

PMA 2026-09-14

Lenses, soft contact, extended wear

Applicant Bausch and Lomb, Inc.,

PMA Number P170035

Class 3

View Details →

PMA 2026-09-14

Stimulator, tibial, electrical, implantable, for urinary incontinence

Applicant Medtronic Neuromodulation

PMA Number P240011

Class 3

View Details →

PMA 2026-09-11

System, hemodynamic, implantable

Applicant ABBOTT MEDICAL

PMA Number P100045

Class 3

View Details →

PMA 2026-09-11

STENT, ILIAC

Applicant Biotronik AG

PMA Number P140030

Class 3

View Details →

PMA 2026-09-11

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Biotronik AG

PMA Number P160025

Class 3

View Details →

PMA 2026-09-11

Valve, pulmonary

Applicant Pulmonx Corporation

PMA Number P180002

Class 3

View Details →

PMA 2026-09-11

Immunohistochemistry assay, antibody, Ki-67

Applicant Agilent Technologies, Inc.

PMA Number P210026

Class 3

View Details →

PMA 2026-09-11

Shockwave intravascular lithotripsy system

Applicant Shockwave Medical, Inc.

PMA Number P200039

Class 3

View Details →

PMA 2026-09-11

Sealant, dural

Applicant Pramand, LLC

PMA Number P240027

Class 3

View Details →

PMA 2026-09-11

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Applicant Agilent Technologies, Inc.

PMA Number P250004

Class 3

View Details →

Page 8 of 80

↑