ADHERUS AUTOSPRAY DURAL SEALANT

Sealant, Dural

FDA Premarket Approval P130014

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the adherus autospray dural sealant. This device is indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as when using sutures, to providewatertight closure during cranial procedures.

DeviceADHERUS AUTOSPRAY DURAL SEALANT
Classification NameSealant, Dural
Generic NameSealant, Dural
ApplicantHYPERBRANCH MEDICAL TECHNOLOGY, INC.
Date Received2013-05-14
Decision Date2015-03-30
Notice Date2015-04-17
PMAP130014
SupplementS
Product CodeNQR
Docket Number15M-1065
Advisory CommitteeNeurology
Expedited ReviewNo
Combination Product No
Applicant Address HYPERBRANCH MEDICAL TECHNOLOGY, INC. 800-12 Capitola Drive durham, NC 27713
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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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