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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 NumberS015
Date Received02/11/2019
Decision Date03/13/2019
Product Code PMX 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the Porcine Collagen Powder (POW04) production process in order to increase the manufacturing capacity of the component. Changes include duplicating existing equipment and optimizing the production process in order to decrease the overall time needed to manufacture a batch of POW04.
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