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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.
 
DeviceHEMOBLAST® Bellows
Generic NameAbsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
ApplicantDilon Technologies, Inc.
12050 Jefferson Ave., Suite 340
Newport News, VA 23606
PMA NumberP170012
Supplement NumberS031
Date Received07/11/2025
Decision Date04/28/2026
Product Code PMX 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03873168
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for removal of the urological exception from the currently approved indications for use.
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