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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(TM) Hydrogel Embolic System
Generic NameEmbolization Agent, Vascular
ApplicantInstylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford, MA 01730
PMA NumberP250003
Supplement NumberS010
Date Received09/21/2026
Decision Date10/21/2026
Product Code QVG 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process 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 product positioning within the pouch prior to moist heat sterilization of the precursor kit of the Embrace Hydrogel Embolic System (HES).
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