Medtech approvals: FDA releases January 2017 PMA approvals

Summary of PMA Originals & Supplements Approved

• Originals: 4
• Supplements: 40

Submission Number	Date Final Decision	Review Track	Trade Name	Appl/Spr Name	Approval Order Statement
P140033	01/31/2017	PMAO – PMA Original	ASSURITY MRI AND ENDURITY MRI PACEMAKERS, TENDRIL MRI LEAD, MRI ACTIVATOR, MERLIN PCS PROGRAMER SOFTWARE	ST. JUDE MEDICAL, INC.	Approval for the MR Conditional Pacemaker System (which includes the Assurity MRI (Models PM 1272, PM 2272) and Endurity MRI (Models PM 1172, PM 2172) pacemakers, Tendril MRI Lead (Model LPA 1200M), MRI Activator (Model EX4000), Merlin PCS Programmer Software (Model 3330 v 22.1.1), Merlin.net MN5000 7.4d, and Merlin@home EX2000 8.2.2). Implantation of a singlechamber pulse generator or dual-chamber pulse generator is indicated for in one or more of the following permananent conditions: 1) Syncope; 2) Presyncope; 3) Fatigue; 4) Disorientation; or 5) Any combination of those symptoms MR Conditional pulse generator is safe for use in the MRI environment when used as a complete MR Conditional pacing system, and according to the instructions in the MRI Procedure Information document for the St. Jude Medical MR Conditional Pacing System. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the agepredicted maximum heart rate or 120 bpm during exercise testing, whichever is less, where the agepredicted heart rate is calculated as 197 (0.56 x age). Dual-Chamber Pacing (Dual-chamber pulse generators) is indicated for those patients exhibiting: 1) Sick sinus syndrome 2)Chronic, symptomatic second- and third-degree AV block 3) Recurrent Adams-Stokes syndrome; and 4) Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: 1) Normal sinus rhythm with only rare episodes of A-V block or sinus arrest 2) Chronic atrial fibrillation; and 3) Severe physical disability.AF Suppression (Dual-chamber pulse generators) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. The Tendril MRI lead is a 7.9 French, transvenous, steroid eluting, bipolar, IS-1 compliant active fixation lead designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active fixation leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of passive fixation leads is suspected to be unstable. In atrial applications, the use of screw-in leads such as Tendril MRI lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage. The MRI Activator handheld device is used to evaluate the status of, and to enable and disable, the previously stored MRI settings. The activator is intended for use with St. Jude Medical MR Conditional pulse generators.
P160008	01/12/2017	PMAO – PMA Original	HEARTSINE TECHNOLOGIES LLC’S SAMARITAN PUBLIC ACCESS AUTOMATED EXTERNAL DEFIBRILLATORS (SAM 350P, SAM 360P AND SAM 450P) AND ACCESSORIES	HEARTSINE TECHNOLOGI ES LLC	Approval for the HeartSine samaritan® PAD 350P (SAM 350P), PAD 360P (SAM 360P), and PAD 450P (SAM 450P) public access automated external defibrillators and battery/electrode accessories. These AEDs are indicated for use on victims of cardiac arrest who are exhibiting the following signs: 1) Unconscious; 2) Not breathing; and 3) Without circulation (without a pulse) The devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physicianauthorized emergency medical response training program. The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pak (PadPak-02).
P160021	01/27/2017	PMAO – PMA Original	GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS	W. L. GORE & ASSOCIATES, INC.	Approval for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5mm – 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.
P160031	01/10/2017	PMAO – PMA Original	i ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.	Approval for the Aspire Cristalle Digital Breast Tomosynthesis Option. The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images, and is intended for use in the screening and diagnosis of breast cancer. A screening examination may consist of sets of CC and MLO images acquired in: 1) the FFDM mode only, or 2) an FFDM image set and a DBT image set acquired in the ST (standard) mode. The FFDM image set and the DBT image set must be acquired with N-mode dose setting, and may be acquired in one compression (Tomo Set mode) or separate compressions (FFDM and DBT modes).

The FDA also released a full list of supplement PMA approvals for the month.

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