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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
6502 slide rd suite 402
lubbock, TX 79401
PMA NumberP120018
Date Received10/23/2012
Decision Date02/17/2016
Product Code
MTV[ Registered Establishments with MTV ]
Docket Number 16M-0806
Notice Date 03/07/2016
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Sharps Terminator. This device is indicated for use by individuals and healthcare professionals to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 cm). The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, Dental Offices, and Clinical Laboratories.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling