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 2017-12-21

Sealant, polymerizing

Applicant Baxter Healthcare Corporation

PMA Number P100030

Class 3

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PMA 2017-12-21

Automated external defibrillators (non-wearable)

Applicant Physio-Control, Inc.

PMA Number P160012

Class 3

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PMA 2017-12-21

Excimer laser system

Applicant Alcon Laboratories, Inc.

PMA Number P030008

Class 3

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PMA 2017-12-19

intraocular lens

Applicant Hoya Surgical Optics, Inc.

PMA Number P080004

Class 3

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PMA 2017-12-19

implantable pacemaker Pulse-generator

Applicant ABBOTT MEDICAL

PMA Number P140033

Class 3

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PMA 2017-12-18

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Life Technologies Corporation

PMA Number P160045

Class 3

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PMA 2017-12-15

heart-valve, non-allograft tissue

Applicant Medtronic, Inc.

PMA Number P170006

Class 3

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PMA 2017-12-15

STENT, CORONARY

Applicant Abbott Vascular

PMA Number P020047

Class 3

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PMA 2017-12-15

Absorbable collagen hemostatic agent with thrombin

Applicant Dilon Technologies, Inc.

PMA Number P170012

Class 3

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PMA 2017-12-14

Implant, cochlear

Applicant Cochlear Americas

PMA Number P890027

Class 3

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PMA 2017-12-14

Implant, cochlear

Applicant Cochlear Americas

PMA Number P840024

Class 3

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PMA 2017-12-13

Temporary non-roller type right heart support blood pump

Applicant Abiomed, Inc.

PMA Number P170011

Class 3

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