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 2016-10-19

Somatic gene mutation detection system

Applicant Roche Molecular Systems, Inc.

PMA Number P150047

Class 3

View Details →

PMA 2016-10-18

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Ventana Medical Systems, Inc.

PMA Number P160006

Class 3

View Details →

PMA 2016-10-14

Laparoscopic contraceptive tubal occlusion device

Applicant Richard Wolf Medical Instruments Corp.

PMA Number P870080

Class 3

View Details →

PMA 2016-10-11

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Obtech Medical GmbH

PMA Number P070009

Class 3

View Details →

PMA 2016-09-28

Somatic gene mutation detection system

Applicant Roche Molecular Systems, Inc.

PMA Number P150044

Class 3

View Details →

PMA 2016-08-18

Optical diagnostic device for melanoma detection

Applicant Strata Skin Sciences, Inc.

PMA Number P090012

Class 2

View Details →

PMA 2016-08-11

Prosthesis, intervertebral disc

Applicant Medtronic Sofamor Danek, Inc.

PMA Number P060018

Class 3

View Details →

PMA 2016-08-10

STENT, CORONARY

Applicant Boston Scientific Scimed, Inc.

PMA Number P020009

Class 3

View Details →

PMA 2016-08-09

Prosthesis, finger, constrained, metal/polymer

Applicant Stryker Corporation

PMA Number P960053

Class 3

View Details →

PMA 2016-08-04

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Applicant Roche Molecular Systems, Inc.

PMA Number P000012

Class 2

View Details →

PMA 2016-06-23

Lenses, soft contact, extended wear

Applicant Alcon Laboratories, Inc.

PMA Number P000030

Class 3

View Details →

PMA 2016-06-23

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P940008

Class 3

View Details →

Page 78 of 80

↑