Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

FDA Premarket Approval P130014 S011

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

The addition of a glove box for storage and handling of the two precursor solutions of the adherus sealant

DeviceAdherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant
Generic NameSealant, Dural
ApplicantHYPERBRANCH MEDICAL TECHNOLOGY, INC.
Date Received2021-04-13
Decision Date2021-04-16
PMAP130014
SupplementS011
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
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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