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 2018-04-13

Agent, absorbable hemostatic, collagen based

Applicant Pfizer, Inc.

PMA Number N18286

Class 3

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PMA 2018-04-11

Placental alpha microglobulin-1 immunoassay

Applicant Qiagen, Inc.

PMA Number P160052

Class 3

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PMA 2018-04-10

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number P980006

Class 3

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PMA 2018-04-06

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P110027

Class 3

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PMA 2018-02-12

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Becton, Dickinson and Company

PMA Number P160037

Class 3

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PMA 2018-01-16

STENT, ILIAC

Applicant Bard Peripheral Vascular, Inc.

PMA Number P080007

Class 3

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PMA 2017-12-29

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

Applicant Abbott Diabetes Care, Inc.

PMA Number P160030

Class 3

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PMA 2017-12-28

Acid, hyaluronic, intraarticular

Applicant Ferring Pharmaceuticals, Inc.

PMA Number P010029

Class 3

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PMA 2017-12-28

Digital breast tomosynthesis

Applicant GE Healthcare

PMA Number P130020

Class 3

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PMA 2017-12-27

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160022

Class 3

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PMA 2017-12-22

Pump, infusion, implanted, programmable

Applicant Medtronic, Inc.

PMA Number P140032

Class 3

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PMA 2017-12-21

Implanted phrenic nerve stimulator for central sleep apnea

Applicant Respicardia

PMA Number P160039

Class 3

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