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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.
 
DeviceSHARPX NEEDLE DESTRUCTION UNIT
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantInnovative Medical Systems, Inc.
3610 Oakdale Dr.
Mountain Brook, AL 35223
PMA NumberP980015
Supplement NumberS005
Date Received05/30/2002
Decision Date06/12/2002
Reclassified Date06/04/2018
Product Code MTV 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE EXPANSION OF THE NEEDLE GAUGE RANGE TO INCLUDE 18-30 GAUGE NEEDLES, AND MINOR LABELING CHANGES.
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