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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSharps Terminator
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantSharps Terminator, LLC
6502 Slide Rd.
Suite 402
Lubbock, TX 79401
PMA NumberP120018
Supplement NumberS001
Date Received05/25/2017
Decision Date02/16/2018
Reclassified Date06/04/2018
Product Code MTV 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Global Machining Industries, 28 Xinchang Road, 2nd Floor, Suzhou Industrial Park, Suzhou 21500, China, Manufacturing.
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