Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 2016-10-11

Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence

Applicant Abbott Molecular

PMA Number P030052

Class 3

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PMA 2016-10-11

Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Applicant Abbott Molecular, Inc.

PMA Number P110012

Class 3

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PMA 2016-10-10

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Ortho-Clinical Diagnostics

PMA Number P100001

Class 2

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PMA 2016-10-07

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant ABBOTT MEDICAL

PMA Number P110016

Class 3

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PMA 2016-10-07

Implant, corneal, refractive

Applicant Corneagen

PMA Number P120023

Class 3

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PMA 2016-10-06

Cross-sectional mammographic xray system

Applicant Koning Corporation

PMA Number P130025

Class 3

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PMA 2016-10-06

Intravascular radiation delivery system

Applicant Best Vascular, Inc.

PMA Number P000018

Class 3

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PMA 2016-10-06

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Abbott Vascular (Idef Technologies Inc)

PMA Number P120020

Class 3

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PMA 2016-10-06

Filler, bone void, synthetic peptide

Applicant Biomimetic Therapeutics, LLC

PMA Number P100006

Class 3

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PMA 2016-10-05

Device, hemostasis, vascular

Applicant Vascular Solutions, Inc.

PMA Number P990037

Class 3

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PMA 2016-10-04

Acid, hyaluronic, intraarticular

Applicant Anika Therapeutics, Inc.

PMA Number P090031

Class 3

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PMA 2016-10-04

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant MicroPort CRM USA, Inc.

PMA Number P980049

Class 3

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