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 2022-04-29

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P150029

Class 3

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PMA 2022-04-14

Coronary drug-eluting stent

Applicant Biosensors International USA, Inc.

PMA Number P190020

Class 3

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PMA 2022-04-08

Lens, intraocular, accommodative

Applicant Bausch & Lomb, Inc.

PMA Number P030002

Class 3

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PMA 2022-03-29

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

Applicant Siemens Healthcare Diagnostics

PMA Number P040004

Class 2

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PMA 2022-03-18

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Applicant Abbott Molecular, Inc.

PMA Number P980024

Class 3

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PMA 2022-03-18

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number P850068

Class 3

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PMA 2022-03-17

Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents

Applicant Datex-Ohmeda, Inc., A General Electric Company

PMA Number P210018

Class 3

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PMA 2022-03-02

System, laser, photodynamic therapy

Applicant Pinnacle Biologics, Inc.

PMA Number P990021

Class 3

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PMA 2022-02-18

Bronchial thermoplasty system

Applicant Boston Scientific Corp

PMA Number P080032

Class 3

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PMA 2022-01-19

intraocular lens

Applicant Bausch & Lomb

PMA Number P910061

Class 3

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PMA 2022-01-04

Implant, corneal, refractive

Applicant Rvo 2.0, Inc. (D.B.A. Optics Medical)

PMA Number P150034

Class 3

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PMA 2021-12-21

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

Applicant DiaSorin, Inc.

PMA Number P990042

Class 2

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