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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSHARPX NEEDLE DESTRUCTION UNIT
Classification Namedevice, needle destruction
Generic Namesharpx needle destruction device
ApplicantINNOVATIVE MEDICAL SYSTEMS, INC.
PMA NumberP980015
Supplement NumberS005
Date Received05/30/2002
Decision Date06/12/2002
Product Code
MTV
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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