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.
| Device | Adherus AutoSpray Dural and ET Dural Sealant |
| Classification Name | Sealant, Dural |
| Generic Name | Sealant, Dural |
| Applicant | HYPERBRANCH MEDICAL TECHNOLOGY, INC. |
| Date Received | 2018-02-12 |
| Decision Date | 2018-07-31 |
| PMA | P130014 |
| Supplement | S005 |
| Product Code | NQR |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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