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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.
 
DeviceSHARP(X)TM 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 NumberS003
Date Received09/14/1999
Decision Date09/17/1999
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 a modification of a contraindication statement in the labeling.
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