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.
| Device | ADHERUS AUTOSPRAY DURAL SEALANT |
| Classification Name | Sealant, Dural |
| Generic Name | Sealant, Dural |
| Applicant | HYPERBRANCH MEDICAL TECHNOLOGY, INC. |
| Date Received | 2013-05-14 |
| Decision Date | 2015-03-30 |
| Notice Date | 2015-04-17 |
| PMA | P130014 |
| Supplement | S |
| Product Code | NQR |
| Docket Number | 15M-1065 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| 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 Number | Date | Supplement Type |
|---|
| P130014 | | Original 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