Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant

FDA Premarket Approval P130014 S013

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

Approval for an additional production apparatus for polyethylene ("peg") sebacate ("sb-1 setup") that is used in the chemical synthesis of peg sebacate

DeviceAdherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant
Generic NameSealant, Dural
ApplicantHYPERBRANCH MEDICAL TECHNOLOGY, INC.
Date Received2021-11-18
Decision Date2021-12-17
PMAP130014
SupplementS013
Product CodeNQR 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HYPERBRANCH MEDICAL TECHNOLOGY, INC. 800-12 Capitola Drive durham, NC 27713

Supplemental Filings

Supplement NumberDateSupplement Type
P130014Original Filing
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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