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 2016-10-28

Transcatheter septal occluder

Applicant ABBOTT MEDICAL

PMA Number P120021

Class 3

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PMA 2016-10-28

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Bard Peripheral Vascular, Inc.

PMA Number P070014

Class 3

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PMA 2016-10-27

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Abbott Laboratories

PMA Number P120008

Class 3

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PMA 2016-10-26

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P050052

Class 3

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PMA 2016-10-26

CATHETER, CORONARY, ATHERECTOMY

Applicant Cardiovascular Systems, Inc.

PMA Number P130005

Class 3

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PMA 2016-10-26

Barrier, absorbable, adhesion

Applicant ETHICON, Inc.

PMA Number P880047

Class 3

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PMA 2016-10-26

Processor, cervical cytology slide, automated

Applicant Hologic, Inc.

PMA Number P950039

Class 3

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PMA 2016-10-26

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P050037

Class 3

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PMA 2016-10-26

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

Applicant Siemens Corp.

PMA Number P110041

Class 2

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PMA 2016-10-25

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Boston Scientific Corporation

PMA Number P140012

Class 3

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PMA 2016-10-25

Agent, absorbable hemostatic, non-collagen based

Applicant ETHICON, Inc.

PMA Number N12159

Class 3

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PMA 2016-10-24

ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)

Applicant Siemens Healthcare Diagnostics

PMA Number P990055

Class 3

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