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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.
 
DeviceNEEDLE-EASE MODEL 3500
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantMillenium Medical Supply, Inc.
The Willard Office Bldg.
1455 Pennsylvania Ave., NW
Washington, D.C. 20004, DC 20004
PMA NumberP960044
Supplement NumberS001
Date Received10/03/1997
Decision Date02/11/1998
Reclassified Date06/04/2018
Product Code MTV 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modified needle destruction device. The device, as modified, will be marketed under the trade name Needle-Ease(R) 3500 and is indicated for the disposal of standard plstic syringe-mounted hypodermic needles and aluminum hubbed dental needles in doctor's and dentist's offices.
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