Approval for a shift in the tolerance range for the nozzle-insert component of the adherus autospray dural sealant
| Device | Adherus AutoSpray Dural Sealant, NUS-106 |
| Generic Name | Sealant, Dural |
| Applicant | HYPERBRANCH MEDICAL TECHNOLOGY, INC. |
| Date Received | 2022-02-09 |
| Decision Date | 2022-02-14 |
| PMA | P130014 |
| Supplement | S014 |
| Product Code | NQR |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HYPERBRANCH MEDICAL TECHNOLOGY, INC. 800-12 Capitola Drive durham, NC 27713 |
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