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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 NumberS001
Date Received12/08/1998
Decision Date12/14/1998
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 device and to the labeling. The modifications to the device were noted to include the addition of a charger base and modifications to the device housing, electrode assembly and filter.
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