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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 NumberS011
Date Received09/10/2018
Decision Date10/10/2018
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  
Increase batch production size during drying, implement the use of stainless steel drying trays, increase storage time of in-process device, and increase the sampling plan throughout the manufacturing process.
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