Nov 1, 2016 - Approval for the Clinician Programmer App (Version 3.3) Model 3874 and .... Approval for a contract manufa
PMA Monthly approvals from 11/1/2016 to 11/30/2016 Original
Submission Number
Date Final Decision
Review Track
Appl/Spr Name
P150043
11/09/2016
PMAO - PMA Origi QVCAD SYSTEM
Trade Name
QVIEW MEDICAL, INC.
Approval Order Statement Approval for the QVCAD System. The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings.
Total: 1 Supplements
Submission Number
Date Final Decision
Review Track
Trade Name
Appl/Spr Name
P830055/S178
11/28/2016
S - Special
LCS(R) TOTAL KNEE SYSTEM
DEPUY, INC.
Approval for the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized.
Approval to add the following contraindication to the labeling: Any surgical implantation procedure such as minimally invasive surgical-MIS procedures requiring the SpF® Spinal Fusion Stimulators cathodes to be disconnected from their corresponding leads prior to or during implantation since this may seriously compromise the electrical performance of the implantable stimulators cathodes to deliver a constant current to the fusion site as intended.
P890003/S365
11/17/2016
R - Real-Time Proc MYCARELINK PATIENT MONITOR MODEL 24950
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMEN T
Approval for software modification to the MyCareLink Patient Monitor Model 24950.
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Approval Order Statement
Data as of 12/08/2016 04: 26 AM
Submission Number
Date Final Decision
Review Track
Trade Name
Appl/Spr Name
P930016/S045
11/14/2016
P - Panel Track
IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM
AMO MANUFACTUR ING USA, LLC
Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for Use: in patients: 1) with mixed astigmatism as measured by iDesign Advanced WaveScan Studio System where the magnitude of cylinder (1.0 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; 2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign Advanced WaveScan Studio System refraction as follows: a) Spherical Equivalent: Magnitude of the difference is less than 0.625 D; b)Cylinder: Magnitude of the difference is less than or equal to 0.5 D.; and c) 18 years of age or older, and with refractive stability (a change of
