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 2021-08-11

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

Applicant Roche Molecular Systems, Inc.

PMA Number P060030

Class 2

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PMA 2021-08-11

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Revvity, Inc.

PMA Number P970037

Class 3

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PMA 2021-08-10

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant DiaSorin, Inc.

PMA Number P190011

Class 2

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PMA 2021-07-26

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant Allergan

PMA Number P040046

Class 3

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PMA 2021-07-19

intraocular lens

Applicant Starr Surgical Co.

PMA Number P990013

Class 3

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PMA 2021-07-07

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P120022

Class 3

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PMA 2021-06-30

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy

Applicant Prostalund AB

PMA Number P010055

Class 3

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PMA 2021-06-29

Stent, iliac vein

Applicant Boston Scientific Corporation

PMA Number P180013

Class 3

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PMA 2021-06-02

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

Applicant Roche Molecular Systems, Inc.

PMA Number P150015

Class 2

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PMA 2021-06-01

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

Applicant Abbott Molecular, Inc.

PMA Number P190025

Class 2

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PMA 2021-05-19

Laparoscopic contraceptive tubal occlusion device

Applicant Gyrus Acmi, Inc.

PMA Number P870076

Class 3

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PMA 2021-04-27

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Siemens Healthcare Diagnostics

PMA Number P030056

Class 2

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