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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.
 
DeviceEmbrace™ Hydrogel Embolic System (HES)
Generic NameEmbolization Agent, Vascular
ApplicantInstylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford, MA 01730
PMA NumberP250003
Supplement NumberS002
Date Received11/18/2025
Decision Date12/17/2025
Product Code QVG 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to update to the PEG percent substitution test method, the Laysan Bio Manufacturing process for PEG, and process specifications by the steam sterilization supplier, Steris
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