Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant

FDA Premarket Approval P130014 S016

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.

Pre-market Approval Supplement Details

DeviceAdherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant
Generic NameSealant, Dural
ApplicantHYPERBRANCH MEDICAL TECHNOLOGY, INC.800-12 Capitola Drivedurham, NC 27713 PMA NumberP130014 Supplement NumberS016 Date Received12/21/2022 Decision Date01/05/2023 Product Code NQR  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-21
Decision Date2023-01-05
PMAP130014
SupplementS016
Product CodeNQR 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressHYPERBRANCH MEDICAL TECHNOLOGY, INC.
800-12 Capitola Drive
durham, NC 27713 PMA NumberP130014 Supplement NumberS016 Date Received12/21/2022 Decision Date01/05/2023 Product Code NQR  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementing A Procedure To Perform Testing Of A Sample From Each Lot Of NHS (N-hydroxylsuccinimide) Raw Material Prior To Purchasing It From The Supplier

Supplemental Filings

Supplement NumberDateSupplement Type
P130014Original Filing
S016 2022-12-21 30-day Notice
S015 2022-03-04 30-day Notice
S014 2022-02-09 30-day Notice
S013 2021-11-18 30-day Notice
S012 2021-08-24 30-day Notice
S011 2021-04-13 30-day Notice
S010 2021-02-23 30-day Notice
S009 2020-11-18 30-day Notice
S008 2020-07-17 30-day Notice
S007 2020-04-13 Real-time Process
S006 2019-08-16 30-day Notice
S005 2018-02-12 Normal 180 Day Track No User Fee
S004 2017-05-03 30-day Notice
S003
S002 2016-02-02 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00897146002018 P130014 000
30897146002026 P130014 002

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