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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.
 
DeviceABSORBABLE DUSTING POWDER
ApplicantKellerandheckman
1001 G St., NW
Suite 500 W.
Washington, DC 20001
PMA NumberN80023
Supplement NumberS001
Date Received02/27/1995
Decision Date02/20/1998
Withdrawal Date07/01/2010
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the manufacturing process.
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