Adherus AutoSpray Dural and ET Dural Sealant

Sealant, Dural

FDA Premarket Approval P130014 S005

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 manufacturing sites located at steris applied sterilization technologies (ast) dba synergy health ast, llc, 7225 north noah drive, saxonburg, pennsylvania 16056 and steris applied sterilization technologies (ast) dba synergy health ast, llc, 3200 lakeville hwy, suite 120, petaluma, california 94954, as contract sterilizers.

DeviceAdherus AutoSpray Dural and ET Dural Sealant
Classification NameSealant, Dural
Generic NameSealant, Dural
ApplicantHYPERBRANCH MEDICAL TECHNOLOGY, INC.
Date Received2018-02-12
Decision Date2018-07-31
PMAP130014
SupplementS005
Product CodeNQR
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation 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
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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