FDA PMA Approvals

Implant, cochlear

Applicant Cochlear Americas

PMA Number P970051

Class 3

Implant, auditory brainstem

Applicant Cochlear Americas

PMA Number P000015

Class 3

Cochlear implant with combined electrical stimulation and acoustic amplification

Applicant Cochlear Americas

PMA Number P130016

Class 3

Gases used within eye to place pressure on detached retina

Applicant Airgas Therapeutics, LLC

PMA Number P900066

Class 3

Stent, vena cava

Applicant W. L. Gore & Associates, Inc.

PMA Number P250017

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Applicant Roche Diagnostics Corp.

PMA Number P000027

Class 2

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Roche Diagnostics Corp.

PMA Number P990056

Class 3

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160033

Class 3

Stent, iliac vein

Applicant Medtronic Vascular, Inc.

PMA Number P200026

Class 3

Gastric Emptying Breath Test

Applicant Advanced Breath Diagnostics

PMA Number P110015

Class 3

Lens, intraocular, phakic

Applicant Ophtec BV

PMA Number P030028

Class 3

Permanent defibrillator electrodes

Applicant Medtronic, Inc.

PMA Number P240036

Class 3