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.
| Device | Adherus ET AutoSpray Dural Sealant, NUS-109 |
| Generic Name | Sealant, Dural |
| Applicant | HYPERBRANCH MEDICAL TECHNOLOGY, INC.800-12 Capitola Drivedurham, NC 27713 PMA NumberP130014 Supplement NumberS015 Date Received03/04/2022 Decision Date03/16/2022 Product Code NQR Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-03-16 |
| PMA | P130014 |
| Supplement | S015 |
| 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 PMA NumberP130014 Supplement NumberS015 Date Received03/04/2022 Decision Date03/16/2022 Product Code NQR Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Steris Applied Technologies Dba Synergy Health AST, LLC Facility Located In Saxonburg, Pennsylvania (Steris AST Saxonburg) To Use A Functionally Equivalent Electron Accelerator To Sterilize Adherus AutoSpray ET Dural Sealants |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00897146002018 | P130014 | 000 |
| 30897146002026 | P130014 | 002 |