Medtech approvals: FDA releases April 2015 PMAs

The FDA released its list of the pre-market approvals it granted for medical devices in April 2015.

Summary of PMA Originals & Supplements Approved

• Originals: 5
• Supplements: 65

Summary of PMA Originals Under Review

• Total Under Review: 60
• Total Active: 31
• Total On Hold: 29

Summary of PMA Supplements Under Review

• Total Under Review: 561
• Total Active: 390
• Total On Hold: 171

Summary of All PMA Submissions

• Originals: 4
• Supplements: 87

Summary of PMA Supplement PMA Approval/Denial Decision Times

• Number of Approvals: 65
• Number of Denials: 0
• Average Days Fr Receipt to Decision (Total Time): 154.1
• FDA Time: 127.9 Days
• MFR Time: 26.2 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P110015 4/6/15	Gastric Emptying Breath Test (GEBT)	Advanced Breath Diagnostics, LLC Brentwood, TN 37027	Approval for the Gastric Emptying Breath Test (GEBT). This device, to be used with the GEBT test meal, is intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis. For these purposes, the test system utilizes a Gas Isotope Ratio Mass Spectrometer (GIRMS) for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The GEBT procedure should be administered under supervision of a health care professional although no specialized facilities or specially licensed personnel are required.
P120017 4/27/15	Model 5071 Lead	Medtronic Inc. Mounds View, MN 55112	Approval for unipolar ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing.
P120023 4/17/15	KAMRA® inlay	AcuFocus™, Inc. Irvine, Ca 92618	Approval for the KAMRA inlay. The KAMRA inlay is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 D to -0.75 D with less than or equal to 0.75 D of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add.
P130012 4/30/15	Myopore Sutureless Myocardial Pacing Leads Models 511210, 511211, 511212	Greatbatch Medical Minneapolis, MN 55441	Approval for the Myopore Sutureless Myocardial Pacing Lead. This device is indicated for when ventricular epicardial attachment is required, or when a transvenous lead cannot provide effective pacing. This type of lead is useful in situations where it is required that the potential for lead dislodgement be diminished or pacing and/or sensing will be established subsequent to open heart surgery.
P140011 4/21/15	MAMMOMAT Inspiration with Tomosynthesis Option	Siemens Medical Solutions USA, Inc. Malvern, PA 19355	Approval for the MAMMOMAT Inspiration with Tomosynthesis Option. This device is indicated for the acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer. Each screening examination may consist of CC and MLO views in: a 2D image set, or a 2D and 3D image set. Note: The screening examination may consist of 2D FFDM images set with or without the 3D  image set.

PMA Supplemental Approvals

APPLICATION NUMBER %2

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