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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 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 NumberS002
Date Received03/18/1999
Decision Date03/19/1999
Reclassified Date06/04/2018
Product Code MTV 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the modifications of the device circuitry.
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